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

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Abdominal Obesity-Metabolic Syndrome

Treatments: Behavioral: control group; Dietary Supplement: meal replacement group

Study type: Interventional

Funder types: Other

Identifiers

NCT02626741

647-2557-EC4

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

meal replacement group

Experimental group

Description:

the participants receive a meal replacement plus life style modification

Treatment:

Dietary Supplement: meal replacement group

Behavioral: control group

control group

Experimental group

Description:

the participants receive life style modification only.

Treatment:

Behavioral: control group