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Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control (nutrition)

Primary Purpose

Obesity, Diet Modification, Nutrient; Excess

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Meal replacement diet
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Meal replacement, calorie restriction, body weight

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy obese subject (BMI >27)
  • Aged between 20 to 80 of both genders with a desire to lose weight.

Exclusion Criteria:

  • Subjects with cancer
  • Hyperglycemic (diabetic)
  • Hypertension,
  • Stroke
  • Renal dysfunction
  • Cardiac or hepatic dysfunctio
  • allergic to the dairy product and eating disorders
  • Pregnancy, nursing (lactating), chain smokers and heavy alcoholic subjects

Sites / Locations

  • Chung Shan Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meal replacement diet

Arm Description

Obese subjects (BMI>27; n=50, male 23, female 27) were requested to replace (intervention) two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks

Outcomes

Primary Outcome Measures

Calorie intake in obese subjects
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal)
Anthropometric parameter
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg)
Anthropometric parameter
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2)
Cardiovascular (CV) risk factors
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in CV risk factor like Homocysteine (umol/L)
Glycemic markers
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in Glycemic marker like FBG (mg/dL)
Lipid profile
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl)

Secondary Outcome Measures

Full Information

First Posted
August 10, 2018
Last Updated
August 20, 2018
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03642925
Brief Title
Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control
Acronym
nutrition
Official Title
Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 21, 2015 (Actual)
Primary Completion Date
January 21, 2016 (Actual)
Study Completion Date
March 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in Taiwanese obese subjects. Various parameters like anthropometric (body weight, body fat, waist circumference), lipid profile (TC, LDL-c and TG), cardiovascular risk factors, glycemic and oxidative markers as well as renal and hepatic markers were evaluated.
Detailed Description
The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects. Obese subjects (BMI>27; n=50, male 23, female 27) were recruited and requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diet Modification, Nutrient; Excess
Keywords
Meal replacement, calorie restriction, body weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects.
Masking
None (Open Label)
Masking Description
it's a Open-label clinical trial
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meal replacement diet
Arm Type
Experimental
Arm Description
Obese subjects (BMI>27; n=50, male 23, female 27) were requested to replace (intervention) two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Meal replacement diet
Intervention Description
Obese subjects were requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.
Primary Outcome Measure Information:
Title
Calorie intake in obese subjects
Description
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal)
Time Frame
8 weeks
Title
Anthropometric parameter
Description
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg)
Time Frame
8 weeks
Title
Anthropometric parameter
Description
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2)
Time Frame
8 Weeks
Title
Cardiovascular (CV) risk factors
Description
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in CV risk factor like Homocysteine (umol/L)
Time Frame
8 Weeks
Title
Glycemic markers
Description
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in Glycemic marker like FBG (mg/dL)
Time Frame
8 Weeks
Title
Lipid profile
Description
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy obese subject (BMI >27) Aged between 20 to 80 of both genders with a desire to lose weight. Exclusion Criteria: Subjects with cancer Hyperglycemic (diabetic) Hypertension, Stroke Renal dysfunction Cardiac or hepatic dysfunctio allergic to the dairy product and eating disorders Pregnancy, nursing (lactating), chain smokers and heavy alcoholic subjects
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung city
State/Province
Taichung
ZIP/Postal Code
40201
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control

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