Protein Supplementation and Weight Loss

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: herbalife protein shake

• Registration Number: NCT02144636
• Lead Sponsor: Diabetes Foundation, India

Brief Summary

This randomized control trial of diet with protein supplementation is being conducted to test the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss and improvement in cardio-metabolic profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-22
• Primary Completion: 2014-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subjects aged between 21 -65 years
2. Subjects with BMI > 23 Kg/m2

Exclusion Criteria

• Inclusion Criteria:

  1. Subjects aged between 21 -65 years
  2. Subjects with BMI > 23 Kg/m2

Exclusion Criteria:

1. Diabetes (type 1 and type 2)
2. Known or documented coronary heart disease (CHD) (including ECG consistent with prior myocardial infraction), cerebrovascular accident (including transient ischemic attack), peripheral vascular disease (including symptoms of claudication)
3. Angina or other chest pain that may indicate CHD by history
4. Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable) by history
5. Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, other investigational drugs within 30 days of study entry
6. Pregnancy or planning pregnancy during the study period by history
7. Uncontrolled hypertension
8. Uncontrolled hypothyroidism
9. Sensitivity or allergy to product by history
10. Subjects who had undergone bypass procedure
11. Any debilitating disease such as tuberculosis, HIV by history .
12. Unwillingness to give written informed consent for participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treament	herbalife protein shake	herbalife protein shake along with exercise

Primary Outcome Measures

Name	Time	Method
weight loss	baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
improvement in lipid profile	baseline - 3 months

Trial Locations

Locations (1)

Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology; 🇮🇳 Delhi, India