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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meal replacement group | Experimental | the participants receive a meal replacement plus life style modification |
|
| control group | Experimental | the participants receive life style modification only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meal replacement group | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants with weight loss unit in kilograms | Change from baseline body weight at 3 months | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kusuma Chaiyasoot, MD | Contact | +66819304743 | kusuma.chs@mahidol.ac.th | |
| Preyanuj Yamwong, MD | Contact | +66897750773 | preyanuj.yam@mahidol.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Kusuma Chaiyasoot, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23404963 | Background | Leader NJ, Ryan L, Molyneaux L, Yue DK. How best to use partial meal replacement in managing overweight or obese patients with poorly controlled type 2 diabetes. Obesity (Silver Spring). 2013 Feb;21(2):251-3. doi: 10.1002/oby.20057. |
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| ID | Term |
|---|---|
| C535554 | Abdominal obesity metabolic syndrome |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| control group | Behavioral | The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months. |
|
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| 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 |
| D008722 | Methods |