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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03642925
Acronym
nutrition
Enrollment
50
Registered
2018-08-22
Start date
2015-11-21
Completion date
2016-03-01
Last updated
2018-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Modification, Nutrient; Excess, Obesity

Keywords

Meal replacement, calorie restriction, body weight

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.

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.

Interventions

DIETARY_SUPPLEMENTMeal 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.

Sponsors

Chung Shan Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

it's a Open-label clinical trial

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Calorie intake in obese subjects8 weeksIntervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal)
Anthropometric parameter8 weeksIntervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg)
Cardiovascular (CV) risk factors8 WeeksIntervention with calorie restricted meal replacement diet for 8 weeks to check the changes in CV risk factor like Homocysteine (umol/L)
Glycemic markers8 WeeksIntervention with calorie restricted meal replacement diet for 8 weeks to check the changes in Glycemic marker like FBG (mg/dL)
Lipid profile8 weeksIntervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026