Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome
SlimWell
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 4, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedDecember 10, 2015
December 1, 2015
1 year
December 4, 2015
December 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Participants with weight loss unit in kilograms
Change from baseline body weight at 3 months
3 months
Secondary Outcomes (3)
Participants with waist circumference change in centimeters
3 months
Participants with triglyceride change in mg/dl.
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
Study Arms (2)
meal replacement group
EXPERIMENTALthe participants receive a meal replacement plus life style modification
control group
EXPERIMENTALthe participants receive life style modification only.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700, Thailand
Related Publications (1)
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.
PMID: 23404963BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kusuma Chaiyasoot, MD
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2015
First Posted
December 10, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2016
Study Completion
April 1, 2016
Last Updated
December 10, 2015
Record last verified: 2015-12