Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.

Detailed Description
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The participants are divided into two groups: intervention group and control group. In the intervention group, the participants receive a meal replacement plus life style modification. In the control group, the participants receive only life style modification. Sample size calculation is 69 participants per group. Primary outcome is to compare the weight loss between the intervention group and control group.

Official Title
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Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome : A Randomized Controlled Trial

Conditions
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Abdominal Obesity-Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: meal replacement group
* Behavioral: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index more than or equal to 25 kg/m2 Patients with metabolic syndrome Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs. Exclusion Criteria: Uncontrolled diabetes patients Patients with gastrointestinal abnormalities Patients with cardiovascular diseases Patients with hematologic disorders Patients with Glomerular filtration rate less than 60 ml/min/1.73m2 Patients with drug or alcohol abuse Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: meal replacement group<br>the participants receive a meal replacement plus life style modification | Dietary Supplement: meal replacement group<br>* The participants will receive SlimWell 60 grams per meal for 2 meals per day plus life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.<br>* Other names: SlimWell;Behavioral: control group<br>* The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.<br>* Other names: only life style modification;|
| Experimental: control group<br>the participants receive life style modification only. | Behavioral: control group<br>* The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.<br>* Other names: only life style modification;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with weight loss unit in kilograms | Change from baseline body weight at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with waist circumference change in centimeters | Change from baseline waist circumference at 3 months | 3 months | 
| Participants with triglyceride change in mg/dl. | Change from baseline triglyceride at 3 months | 3 months | 
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study meal replacement, Graded According to NCI CTCAE Version 3.0 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study meal replacement, Graded According to NCI CTCAE Version 3.0 focus on Gastrointestinal side effects. | 3 months |