Abdominal Obesity-Metabolic Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTmeal 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.
BEHAVIORALcontrol group
The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants with weight loss unit in kilograms | 3 months | Change from baseline body weight at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Thailand
Contacts
Primary ContactKusuma Chaiyasoot, MD
Backup ContactPreyanuj Yamwong, MD
Outcome results
None listed