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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Mahidol University

Current Primary Outcome: Participants with weight loss unit in kilograms [ Time Frame: 3 months ]

Change from baseline body weight at 3 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Participants with waist circumference change in centimeters [ Time Frame: 3 months ]
    Change from baseline waist circumference at 3 months
  • Participants with triglyceride change in mg/dl. [ Time Frame: 3 months ]
    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 [ Time Frame: 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 focus on Gastrointestinal side effects.


Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: December 4, 2015
Date Started: February 2015
Date Completion: April 2016
Last Updated: December 8, 2015
Last Verified: December 2015