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

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

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

Study Overview

• Status: Unknown
• Conditions: Abdominal Obesity-Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: meal replacement group; Behavioral: control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Faculty of Medicine Siriraj Hospital, Mahidol University
    • Contact: Kusuma Chaiyasoot, MD; Phone Number: +66819304743; Email: kusuma.chs@mahidol.ac.th
    • Principal Investigator: Kusuma Chaiyasoot, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: meal replacement group; the participants receive a meal replacement plus life style modification	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.; Other Names: SlimWell; 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.; Other Names: only life style modification
Experimental: control group; the participants receive life style modification only.	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.; Other Names: only life style modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants with weight loss unit in kilograms	Change from baseline body weight at 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants with waist circumference change in centimeters	Change from baseline waist circumference at 3 months	3 months
Participants with triglyceride change in mg/dl.	Change from baseline triglyceride at 3 months	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.	3 months

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Kusuma Chaiyasoot, MD, Mahidol University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Estimate): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Body Weight Changes; Syndrome; Obesity; Metabolic Syndrome; Weight Loss; Obesity, Abdominal
• Other Study ID Numbers: 647-2557-EC4