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

Phase 3

• Conditions: Abdominal Obesity-Metabolic Syndrome
• Interventions: Behavioral: control group; Dietary Supplement: meal replacement group

• Registration Number: NCT02626741
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-02
• Status Verified: 2015-12
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-08
• Study First Posted: 2015-12-10
• Last Update Posted: 2015-12-10
• Primary Completion: 2016-02
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	control group	the participants receive life style modification only.
meal replacement group	control group	the participants receive a meal replacement plus life style modification
meal replacement group	meal replacement group	the participants receive a meal replacement plus life style modification

Primary Outcome Measures

Name	Time	Method
Participants with weight loss unit in kilograms	3 months	Change from baseline body weight at 3 months

Secondary Outcome Measures

Name	Time	Method
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	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 focus on Gastrointestinal side effects.
Participants with waist circumference change in centimeters	3 months	Change from baseline waist circumference at 3 months
Participants with triglyceride change in mg/dl.	3 months	Change from baseline triglyceride at 3 months

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand