The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
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.
The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand
RECRUITINGParticipants with weight loss unit in kilograms
Change from baseline body weight at 3 months
Time frame: 3 months
Participants with waist circumference change in centimeters
Change from baseline waist circumference at 3 months
Time frame: 3 months
Participants with triglyceride change in mg/dl.
Change from baseline triglyceride at 3 months
Time frame: 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.
Time frame: 3 months
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