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

Last updated: December 8, 2015
Sponsor: Mahidol University
Overall Status: Trial Status Unknown

Phase

3

Condition

Obesity

Metabolic Syndrome

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT02626741
647-2557-EC4
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 lipidlowering drugs.

Exclusion

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

Total Participants: 138
Study Start date:
February 01, 2015
Estimated Completion Date:
April 30, 2016

Study 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.

Connect with a study center

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Active - Recruiting

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