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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Diet Modification, Nutrient; Excess

Intervention / Treatment
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* Dietary Supplement: Meal replacement diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal replacement diet<br>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 | Dietary Supplement: Meal replacement diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calorie intake in obese subjects | Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal) | 8 weeks | 
| Anthropometric parameter | Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg) | 8 weeks | 
| Anthropometric parameter | Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2) | 8 Weeks | 
| 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) | 8 Weeks | 
| Glycemic markers | Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in Glycemic marker like FBG (mg/dL) | 8 Weeks | 
| Lipid profile | Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meal replacement, calorie restriction, body weight