## Protocol Section
### Identification Module
**NCT ID:** NCT06429410

**Brief Title:** Effects of Milk Powder Intervention on Body Composition and Physical Performance in Middle-aged and Older Adults

**Official Title:** Effects of Daily Supplementation With Milk Powder on Body Composition and Physical Performance in Middle-aged and Older Adults: A Randomized Control Trial

#### Organization Study ID Info
**ID:** MN-2024-04
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2026-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Huilian Zhu

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** Huilian Zhu

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study aims to conduct a 24-week intervention involving formula milk powder for middle-aged and elderly individuals, assessing its impact on body composition and physical performance in comparison to interventions using regular milk powder and individuals without intervention.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Fortified formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks.

**Intervention Names:**

- Dietary Supplement: fortified formula milk powder

**Label:** fortified formula milk powder group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks.

**Intervention Names:**

- Dietary Supplement: formula milk powder

**Label:** formula milk powder group

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.

**Intervention Names:**

- Dietary Supplement: regular milk powder

**Label:** regular milk powder group

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** Participants in the observation group did not receive any supplementation.

**Label:** observation group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- fortified formula milk powder group

**Description:** Fortified formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate per day orally for 24 weeks.

**Name:** fortified formula milk powder

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- formula milk powder group

**Description:** Formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate per day orally for 24 weeks.

**Name:** formula milk powder

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- regular milk powder group

**Description:** Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.

**Name:** regular milk powder

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition.

**Measure:** lean body mass

**Time Frame:** up to 24 weeks

#### Secondary Outcomes

**Description:** At baseline, and 24 weeks, investigators will use cardiopulmonary exercise testing (CPET) on a cycle ergometer to evaluate cardiorespiratory fitness.

**Measure:** cardiorespiratory fitness

**Time Frame:** up to 24 weeks

**Description:** At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength.

**Measure:** muscle strength

**Time Frame:** up to 24 weeks

**Description:** At baseline, 12, and 24 weeks, investigators will test the Short Physical Performance Battery (SPPB) to assess muscular function.

**Measure:** physical performance

**Time Frame:** up to 24 weeks

**Description:** At baseline, and 24 weeks, blood samples will be drawn and serum indexes of bone and muscle metabolism will be test, including myostatin, PINP, CTx, and osteocalcin.

**Measure:** the levels of blood metabolic markers for bone and muscle

**Time Frame:** up to 24 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 50 years old and older;
* BMI \<22kg/m2;
* Calf circumference \<33cm in women or \<34cm in men, or SARC-F ≥ 4, or SARC-Claf ≥ 11;
* Living in Guangzhou and having no plan to move in the next 6 months;
* Willing to participate in the study.

Exclusion Criteria:

* Lactose intolerance;
* Complicated with severe diseases;
* Unable to conduct study procedures;
* Participating in any other intervention studies.

**Healthy Volunteers:** True

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Vi

- Name: Vitamins

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17550

- Name: Vitamin D

- Relevance: LOW

- As Found: Unknown

- ID: M6003

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: T479

- Name: Vitamin D3

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

- ID: T435

- Name: Whey Protein

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
