Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome

Abdominal Obesity-Metabolic Syndrome Clinical Trial

— SlimWell  

Official title:

Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome : A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02626741
• Other study ID #: 647-2557-EC4
• Status: Recruiting
• Phase: Phase 3
• First received: December 4, 2015
• Last updated: December 8, 2015
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: December 2015
• Source: Mahidol University
• Contact: Kusuma Chaiyasoot, MD
• Phone: +66819304743
• Email: kusuma.chs[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity-Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Obesity, Abdominal
• Syndrome

Intervention

Dietary Supplement:
• 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.

Behavioral:
• control group
The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with weight loss unit in kilograms	Change from baseline body weight at 3 months	3 months	No
Secondary	Participants with waist circumference change in centimeters	Change from baseline waist circumference at 3 months	3 months	No
Secondary	Participants with triglyceride change in mg/dl.	Change from baseline triglyceride at 3 months	3 months	No
Secondary	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	Yes