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

Obesity Clinical Trial

— nutrition  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642925
• Other study ID #: CS15124
• Status: Completed
• Phase: N/A
• Start date: November 21, 2015
• Est. completion date: March 1, 2016

Study information

• Verified date: August 2018
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2016
• Est. primary completion date: January 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diet Modification
• Nutrient; Excess
• Obesity

Intervention

Dietary Supplement:
• Meal replacement diet
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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung city	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calorie intake in obese subjects	Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal)	8 weeks
Primary	Anthropometric parameter	Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg)	8 weeks
Primary	Anthropometric parameter	Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2)	8 Weeks
Primary	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
Primary	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
Primary	Lipid profile	Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl)	8 weeks