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Completed

NCT Number: NCT03642925

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

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.

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Key information

Conditions

Obesity Body Weight Diet Modification Nutrient; Excess Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 40201, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. Anthropometric parameter

    Time frame: 8 weeks

    Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg)

  3. Anthropometric parameter

    Time frame: 8 Weeks

    Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2)

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Acronym: nutrition

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2018
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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