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

August 20, 2018 updated by: Chin Kun Wang, Chung Shan Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taichung
      • Taichung city, Taichung, Taiwan, 40201
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calorie intake in obese subjects
Time Frame: 8 weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal)
8 weeks
Anthropometric parameter
Time Frame: 8 weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg)
8 weeks
Anthropometric parameter
Time Frame: 8 Weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2)
8 Weeks
Cardiovascular (CV) risk factors
Time Frame: 8 Weeks
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
Time Frame: 8 Weeks
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
Time Frame: 8 weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2015

Primary Completion (ACTUAL)

January 21, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (ACTUAL)

August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS15124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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