NCT02626741

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Obesity-Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	meal replacement group	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.
BEHAVIORAL	control group	The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2015-12-10
• Last updated: 2015-12-10

Locations

1 site across 1 country: Thailand