Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome (SlimWell)
Primary Purpose
Abdominal Obesity-Metabolic Syndrome
Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
meal replacement group
control group
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity-Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
meal replacement group
control group
Arm Description
the participants receive a meal replacement plus life style modification
the participants receive life style modification only.
Outcomes
Primary Outcome Measures
Participants with weight loss unit in kilograms
Change from baseline body weight at 3 months
Secondary Outcome Measures
Participants with waist circumference change in centimeters
Change from baseline waist circumference at 3 months
Participants with triglyceride change in mg/dl.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02626741
Brief Title
Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome
Acronym
SlimWell
Official Title
Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity-Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
meal replacement group
Arm Type
Experimental
Arm Description
the participants receive a meal replacement plus life style modification
Arm Title
control group
Arm Type
Experimental
Arm Description
the participants receive life style modification only.
Intervention Type
Dietary Supplement
Intervention Name(s)
meal replacement group
Other Intervention Name(s)
SlimWell
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
control group
Other Intervention Name(s)
only life style modification
Intervention Description
The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
Primary Outcome Measure Information:
Title
Participants with weight loss unit in kilograms
Description
Change from baseline body weight at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Participants with waist circumference change in centimeters
Description
Change from baseline waist circumference at 3 months
Time Frame
3 months
Title
Participants with triglyceride change in mg/dl.
Description
Change from baseline triglyceride at 3 months
Time Frame
3 months
Title
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
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kusuma Chaiyasoot, MD
Phone
+66819304743
Email
kusuma.chs@mahidol.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Preyanuj Yamwong, MD
Phone
+66897750773
Email
preyanuj.yam@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kusuma Chaiyasoot, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kusuma Chaiyasoot, MD
Phone
+66819304743
Email
kusuma.chs@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Kusuma Chaiyasoot, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23404963
Citation
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.
Results Reference
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Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome
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