Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome
NCT ID: NCT02626741
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
138 participants
INTERVENTIONAL
2015-02-28
2016-04-30
Brief Summary
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Detailed Description
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Sample size calculation is 69 participants per group. Primary outcome is to compare the weight loss between the intervention group and control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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meal replacement group
the participants receive a meal replacement plus life style modification
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.
control group
The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
control group
the participants receive life style modification only.
control group
The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
Interventions
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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.
control group
The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with metabolic syndrome
* Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Kusuma Chaiyasoot, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Kusuma Chaiyasoot, MD
Role: primary
References
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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.
Other Identifiers
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647-2557-EC4
Identifier Type: -
Identifier Source: org_study_id