## Protocol Section
### Identification Module
**NCT ID:** NCT02935179

**Brief Title:** The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity

**Official Title:** Office of Human Research, Taipei Medical University

#### Organization Study ID Info
**ID:** N201604045
#### Organization
**Class:** OTHER
**Full Name:** Taipei Medical University
### Status Module
#### Completion Date
**Date:** 2017-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-04-30

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-04-17

**Type:** ACTUAL

**Results First Submit Date:** 2018-01-25

**Results First Submit QC Date:** 2019-04-15

#### Start Date
**Date:** 2016-07

**Status Verified Date:** 2016-06

#### Study First Post Date
**Date:** 2016-10-17
**Type:** ESTIMATED
**Study First Submit Date:** 2016-10-14
**Study First Submit QC Date:** 2016-10-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Taipei Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this project is to use white-skinned sweet potato as the main material for weight control for overweight and obesity, the non-communicable diseases (cardiovascular diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and health food that to do functional study in Shih Chien University and Taipei Medical University. In this study, the investigators will recruit overweight and obesity subjects that divide into white sweet potato group (experimental group) and no intervention group (control group) by using randomized, parallel and open clinical study in sixty days.

**Detailed Description:** All subjects will be evaluated the body weight and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.

### Conditions Module

**Conditions:**

- Overweight

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Normal diet with 1500\~2000 kcal

**Intervention Names:**

- Dietary Supplement: White sweet potato diet

**Label:** Control Group

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** White sweet potato diet with 1500\~2000 kcal

**Intervention Names:**

- Dietary Supplement: White sweet potato diet

**Label:** Treatment Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group

- Treatment Group

**Description:** The diet were supplied 516 kcal daily

**Name:** White sweet potato diet

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Body weight change after 60 days intervention

**Measure:** Body Weight After Intervention

**Time Frame:** 60 days

#### Secondary Outcomes

**Description:** Body fat change after 60 days intervention

**Measure:** Body Fat After Intervention

**Time Frame:** 60 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 24≦ BMI≦30

Exclusion Criteria:

* Pregnant and lactating women
* Patients within six months after surgery
* Mental illness or depression
* Suffering from cancer, ulcers, acute respiratory infections, dialysis, acute hepatitis and other diseases
* Those who have taken "additional nutritional supplements" habit

**Maximum Age:** 50 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Office of Human Research, Taipei Medical University

**Name:** Chih-Han Lin, MS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** No adverse event.

#### Event Groups

**Group ID:** EG000

**Title:** Control Group

**Deaths Num At Risk:** 29

**Description:** Normal diet

White sweet potato meal replacement: The formula were supplied 516 kcal daily

**ID:** EG000

**Other Num at Risk:** 29

**Serious Number At Risk:** 29

**Title:** Control Group

**Group ID:** EG001

**Title:** Treatment Group

**Deaths Num At Risk:** 29

**Description:** Normal diet plus white sweet potato formula

White sweet potato meal replacement: The formula were supplied 516 kcal daily

**ID:** EG001

**Other Num at Risk:** 29

**Serious Number At Risk:** 29

**Title:** Treatment Group

**Frequency Threshold:** 0

**Time Frame:** The adverse event data were collected from the participants during intervention and assessed after 24 weeks.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 29

**Group ID:** BG001

**Value:** 29

**Group ID:** BG002

**Value:** 58

**Units:** Participants

### Group

**ID:** BG000

**Title:** Control Group

**Description:** Normal diet

White sweet potato meal replacement: The formula were supplied 516 kcal daily

### Group

**ID:** BG001

**Title:** Treatment Group

**Description:** Normal diet plus white sweet potato formula

White sweet potato meal replacement: The formula were supplied 516 kcal daily

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 5.51

**Value:** 37.33

#### Measurement

**Group ID:** BG001

**Spread:** 6.24

**Value:** 38.76

#### Measurement

**Group ID:** BG002

**Spread:** 5.89

**Value:** 38.07

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 28

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Small sample size and trial duration that may cause impose an obstacle in the detection of significant changes of the study measure.
### Point of Contact
**Email:** sinchung@tmu.edu.tw
**Organization:** Taipei Medical University
**Phone:** 886-2-27361661
**Phone Extension:** 6560
**Title:** Dr. Sing-Chung Li
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.7
- **Upper Limit:** 
- **Value:** -2.11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.24
- **Upper Limit:** 
- **Value:** -3.7
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.21
- **Upper Limit:** 
- **Value:** -0.95
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.09
- **Upper Limit:** 
- **Value:** -2.26
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Body weight change after 60 days intervention
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 60 days
**Title:** Body Weight After Intervention
**Type:** PRIMARY
**Unit of Measure:** Kg
##### Group
**Description:** Normal diet

White sweet potato meal replacement: The formula were supplied 516 kcal daily
**ID:** OG000
**Title:** Control Group
##### Group
**Description:** Normal diet plus white sweet potato formula

White sweet potato meal replacement: The formula were supplied 516 kcal daily
**ID:** OG001
**Title:** Treatment Group
#### Outcome Measure 2
**Description:** Body fat change after 60 days intervention
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 60 days
**Title:** Body Fat After Intervention
**Type:** SECONDARY
**Unit of Measure:** percentage of body fat
##### Group
**Description:** Normal diet

White sweet potato meal replacement: The formula were supplied 516 kcal daily
**ID:** OG000
**Title:** Control Group
##### Group
**Description:** Normal diet plus white sweet potato formula

White sweet potato meal replacement: The formula were supplied 516 kcal daily
**ID:** OG001
**Title:** Treatment Group
### Participant Flow Module
#### Group
**Description:** Normal diet

White sweet potato meal replacement: The formula were supplied 516 kcal daily
**ID:** FG000
**Title:** Control Group
#### Group
**Description:** Normal diet plus white sweet potato formula

White sweet potato meal replacement: The formula were supplied 516 kcal daily
**ID:** FG001
**Title:** Treatment Group
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 30
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 30
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 29
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 29
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Has Results:** True