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

NCT03642925 | Completed DMC

• 1 other identifier: CS15124
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diet Modification; Nutrient; Excess

Keywords

Meal replacement; calorie restriction; body weight

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Meal replacement diet

EXPERIMENTAL

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

Interventions

Meal replacement diet DIETARY_SUPPLEMENT

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.

Meal replacement diet

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: it's a Open-label clinical trial
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 22, 2018
• Study Start: November 21, 2015
• Primary Completion: January 21, 2016
• Study Completion: March 1, 2016
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)