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

Not Applicable

Completed

• Conditions: Obesity; Diet Modification; Nutrient; Excess
• Interventions: Dietary Supplement: Meal replacement diet

• Registration Number: NCT03642925
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2015-11-21
• Primary Completion: 2016-01-21
• Study Completion: 2016-03-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-20
• Last Update Submitted: 2018-08-20
• Study First Posted: 2018-08-22
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meal replacement diet	Meal replacement diet	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung city, Taichung, Taiwan