## Protocol Section
### Identification Module
**NCT ID:** NCT01607879

**Brief Title:** Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation

**Official Title:** Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy

#### Organization Study ID Info
**ID:** 00016781
#### Organization
**Class:** OTHER
**Full Name:** Medical College of Wisconsin
### Status Module
#### Completion Date
**Date:** 2021-02-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-22

**Type:** ACTUAL

**Last Update Submit Date:** 2023-09-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-09-22

**Type:** ACTUAL

**Results First Submit Date:** 2023-07-18

**Results First Submit QC Date:** 2023-09-20

#### Start Date
**Date:** 2014-03

**Status Verified Date:** 2023-09

#### Study First Post Date
**Date:** 2012-05-30
**Type:** ESTIMATED
**Study First Submit Date:** 2012-04-20
**Study First Submit QC Date:** 2012-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical College of Wisconsin

#### Responsible Party

**Investigator Affiliation:** Medical College of Wisconsin

**Investigator Full Name:** Kathryn A Bylow, MD

**Investigator Title:** Associate Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.

**Detailed Description:** It is well established that older patients experience age-related loss of muscle mass and function (sarcopenia), presumably due to an imbalance of protein synthesis versus protein breakdown. In addition, studies have shown that men who start on ADT experience increased muscle protein breakdown and decreased synthesis. β-hydroxy-β-methylbutyrate (HMB), a leucine metabolite, has been shown to slow protein breakdown. When HMB is given with arginine and lysine (which support protein synthesis) in randomized trials, researchers have shown that elderly men and women who receive this nutritional supplementation experience improvement in fat-free mass, strength, functionality and protein synthesis when compared with controls. In addition, patients with advanced cancer who experienced weight loss of at least 5% have also been shown to benefit from HMB, with supplementation resulting in a significant increase of fat-free mass when compared to controls. Thus, it seems reasonable that older men with prostate cancer starting on ADT who experience lean muscle loss as a result of aging and ADT, may achieve some benefit from supplementation with HMB as well. Use of HMB in men with prostate cancer has not been reported.

### Conditions Module

**Conditions:**

- Prostate Cancer

**Keywords:**

- Prostate Cancer

- Men

- Androgen Deprivation Therapy

- Elderly

- Geriatric

- Nutritional supplementation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

**Intervention Names:**

- Drug: Standard of care ADT + (HMB + arginine + glutamine)

**Label:** Standard of care ADT + (HMB + AG)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard of care androgen deprivation therapy

**Intervention Names:**

- Other: Standard of care ADT

**Label:** Standard of care ADT

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Standard of care ADT + (HMB + AG)

**Description:** 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months

**Name:** Standard of care ADT + (HMB + arginine + glutamine)

**Other Names:**

- Juven

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Standard of care ADT

**Description:** Patient will receive standard of care androgen deprivation therapy (ADT) alone

**Name:** Standard of care ADT

**Other Names:**

- Standard of care androgen deprivation therapy (ADT)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** This measure will be the change of lean body mass from baseline reported in kilograms.

**Measure:** Change From Baseline in Body Composition (Lean Body Mass)

**Time Frame:** Baseline, 3 months

#### Secondary Outcomes

**Description:** Cross-sectional area of the dorsiflexor muscle will be measured in mm\^2 using magnetic resonance imaging. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground. One dorsiflexor muscle in one leg was analyzed per participant.

**Measure:** Change From Baseline of Dorsiflexor Muscle Size in mm^2.

**Time Frame:** Baseline and 3 months

**Description:** Dorsiflexor muscle strength in kilograms will be measured with a custom lower leg ergometer. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground.

**Measure:** Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms.

**Time Frame:** Baseline and 3 months

**Description:** The SPPB uses Likert-style ratings for balance, walking speed, and standing test (Guralnik, 2000).

Balance metric is the ability to hold three standing positions (feet side-by-side; side of the heel of one foot touching the big toe of the other foot; heel of one foot in front of and touching the toes of the other) up to 10 seconds. Inability to hold a position scores '0'. The sum of scores is the Balance Score. Scoring range is 0-4. Higher scores indicate better balance.

Walking metric is time to walk 8 feet. Faster times score more points. Inability to complete the walk scores '0'. The score range is 0-4. Higher scores indicate better mobility.

The Standing Test. The subject is asked to stand and sit five times as quickly as possible. Inability to complete five repetitions scores '0'. Shorter times score more points. Scoring range is 0-4. Higher scores indicate better mobility.

Overall score is the sum of the scores ranging 0 to 12. Higher scores indicate better performance.

**Measure:** Physical Performance Measured Using the Short Physical Performance Battery (SPPB)

**Time Frame:** Baseline and 3 months

**Description:** This measure will be the change in the number of reported falls from baseline (defined as the 3 months preceding the baseline visit), and the 3 month period beginning after the baseline visit and continuing through 3 months of therapy.

**Measure:** Change From Baseline in the Number of Fall Events

**Time Frame:** Baseline, 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate
2. Age 60 years or older
3. Patients with asymptomatic or minimally symptomatic prostate cancer for which they are about to start androgen deprivation therapy (ADT) per provider recommendation

   * Asymptomatic or minimally symptomatic (as judged by treating physician) metastases allowed
   * Men receiving ADT for localized prostate cancer are allowed
4. Patient able to give informed consent.

Exclusion Criteria:

1. Patient already on ADT
2. Patients who are visiting clinic for a second opinion only
3. Patients with a diagnosis of dementia
4. Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)

**Minimum Age:** 60 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Milwaukee

**Country:** United States

**Facility:** Froedtert Hospital and the Medical College of Wisconsin

**State:** Wisconsin

**Zip:** 53226

#### Overall Officials

**Official 1:**

**Affiliation:** Medical College of Wisconsin

**Name:** Kathryn Bylow, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.

**PMID:** 10811152

## Document Section

### Large Document Module

#### Large Docs

- Date: 2015-08-14

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 241191

- Type Abbrev: Prot_SAP

- Upload Date: 2022-12-01T15:06

- Date: 2018-10-01

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 198518

- Type Abbrev: ICF

- Upload Date: 2022-12-01T15:07

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M4059

- Name: Androgens

- Relevance: HIGH

- As Found: Prognostic

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: T1

- Name: Arginine

- Relevance: HIGH

- As Found: Radical

- ID: T6

- Name: Glutamine

- Relevance: HIGH

- As Found: Bladder Cancer

### Intervention Browse Module - Meshes

- ID: D000000728

- Term: Androgens

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Standard of Care ADT + (HMB + AG)

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 24

**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months

**ID:** EG000

**Other Num Affected:** 8

**Other Num at Risk:** 24

**Serious Number Affected:** 1

**Serious Number At Risk:** 24

**Title:** Standard of Care ADT + (HMB + AG)

**Group ID:** EG001

**Title:** Standard of Care ADT

**Deaths Num At Risk:** 24

**Description:** Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone

**ID:** EG001

**Other Num Affected:** 7

**Other Num at Risk:** 24

**Serious Number Affected:** 2

**Serious Number At Risk:** 24

**Title:** Standard of Care ADT

**Frequency Threshold:** 0

#### Other Events

**Term:** Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE 4.0

**Term:** Face pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Hand pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Joint pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Melanoma

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Neoplasm - other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTCAE (4.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Transient ischemic event

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Incontinence, Urinary

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Urinary frequency/urgency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Urinary retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (4.0)

#### Serious Events

**Term:** Leukocytes decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE 4.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 24

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Multi-organ failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE 4.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Transient ischemic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE 4.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 24

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Time Frame:** 8 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 24

**Group ID:** BG001

**Value:** 24

**Group ID:** BG002

**Value:** 48

**Units:** Participants

### Group

**ID:** BG000

**Title:** Standard of Care ADT + (HMB + AG)

**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months

### Group

**ID:** BG001

**Title:** Standard of Care ADT

**Description:** Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 13

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 35

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 5.6

**Value:** 70.6

#### Measurement

**Group ID:** BG001

**Spread:** 5.1

**Value:** 67.4

#### Measurement

**Group ID:** BG002

**Spread:** 5.6

**Value:** 69.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 24

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 48

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 47

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 24

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 46

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 24

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 48

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** kbylow@mcw.edu
**Organization:** Froedtert and the Medical college of Wisconsin
**Phone:** 414-805-4600
**Title:** Kathryn Bylow, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1497
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 1 sided
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.17
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.75
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.925
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 1.0
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.66
- **Upper Limit:** 
- **Value:** 54.93
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.39
- **Upper Limit:** 
- **Value:** 57.58
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.42
- **Upper Limit:** 
- **Value:** -1.27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.22
- **Upper Limit:** 
- **Value:** -0.60
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 322
- **Upper Limit:** 
- **Value:** 1378
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 177
- **Upper Limit:** 
- **Value:** 1348
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 37
- **Upper Limit:** 
- **Value:** -36
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 164
- **Upper Limit:** 
- **Value:** 30
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.1
- **Upper Limit:** 
- **Value:** 17.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.0
- **Upper Limit:** 
- **Value:** 18.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.3
- **Upper Limit:** 
- **Value:** -1.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.0
- **Upper Limit:** 
- **Value:** 1.0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** 10.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.7
- **Upper Limit:** 
- **Value:** 10.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.1
- **Upper Limit:** 
- **Value:** 11.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.2
- **Upper Limit:** 
- **Value:** 11.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 20
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** -1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 21
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** This measure will be the change of lean body mass from baseline reported in kilograms.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 3 months
**Title:** Change From Baseline in Body Composition (Lean Body Mass)
**Type:** PRIMARY
**Unit of Measure:** Kilogram
##### Group
**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months
**ID:** OG000
**Title:** Standard of Care ADT + (HMB + AG)
##### Group
**Description:** Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
**ID:** OG001
**Title:** Standard of Care ADT
#### Outcome Measure 2
**Description:** Cross-sectional area of the dorsiflexor muscle will be measured in mm\^2 using magnetic resonance imaging. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground. One dorsiflexor muscle in one leg was analyzed per participant.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Due to unavailability of equipment, only 5 subjects in the HMB+AG group and 8 subjects in the standard ADT therapy group completed both baseline and 3 months follow-up measurements.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 3 months
**Title:** Change From Baseline of Dorsiflexor Muscle Size in mm^2.
**Type:** SECONDARY
**Unit of Measure:** mm^2
##### Group
**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months
**ID:** OG000
**Title:** Standard of Care ADT + (HMB + AG)
##### Group
**Description:** Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
**ID:** OG001
**Title:** Standard of Care ADT
#### Outcome Measure 3
**Description:** Dorsiflexor muscle strength in kilograms will be measured with a custom lower leg ergometer. The dorsiflexor muscles at the front of the leg are responsible for lifting the ball of the foot with the heel in contact with the ground.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Due to unavailability of equipment, only 5 subjects in the HMB+AG group and 10 subjects in the standard ADT group completed both baseline and 3 month follo-up visits.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 3 months
**Title:** Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms.
**Type:** SECONDARY
**Unit of Measure:** kilogram
##### Group
**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months
**ID:** OG000
**Title:** Standard of Care ADT + (HMB + AG)
##### Group
**Description:** Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
**ID:** OG001
**Title:** Standard of Care ADT
#### Outcome Measure 4
**Description:** The SPPB uses Likert-style ratings for balance, walking speed, and standing test (Guralnik, 2000).

Balance metric is the ability to hold three standing positions (feet side-by-side; side of the heel of one foot touching the big toe of the other foot; heel of one foot in front of and touching the toes of the other) up to 10 seconds. Inability to hold a position scores '0'. The sum of scores is the Balance Score. Scoring range is 0-4. Higher scores indicate better balance.

Walking metric is time to walk 8 feet. Faster times score more points. Inability to complete the walk scores '0'. The score range is 0-4. Higher scores indicate better mobility.

The Standing Test. The subject is asked to stand and sit five times as quickly as possible. Inability to complete five repetitions scores '0'. Shorter times score more points. Scoring range is 0-4. Higher scores indicate better mobility.

Overall score is the sum of the scores ranging 0 to 12. Higher scores indicate better performance.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Four subjects in the HMB+AG group and one subject in the standard ADT group did not complete the SPPB test at the 3-month follow-up.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 3 months
**Title:** Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months
**ID:** OG000
**Title:** Standard of Care ADT + (HMB + AG)
##### Group
**Description:** Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
**ID:** OG001
**Title:** Standard of Care ADT
#### Outcome Measure 5
**Description:** This measure will be the change in the number of reported falls from baseline (defined as the 3 months preceding the baseline visit), and the 3 month period beginning after the baseline visit and continuing through 3 months of therapy.
**Parameter Type:** NUMBER
**Population Description:** Three subjects in the HMB+AG group did not report the number of falls at the 3-month follow-up.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 3 months
**Title:** Change From Baseline in the Number of Fall Events
**Type:** SECONDARY
**Unit of Measure:** Falls
##### Group
**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months
**ID:** OG000
**Title:** Standard of Care ADT + (HMB + AG)
##### Group
**Description:** Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
**ID:** OG001
**Title:** Standard of Care ADT
### Participant Flow Module
#### Group
**Description:** Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months
**ID:** FG000
**Title:** Standard of Care ADT + (HMB + AG)
#### Group
**Description:** Standard of care androgen deprivation therapy

Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone
**ID:** FG001
**Title:** Standard of Care ADT
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 24
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 23
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 24
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True