Protein Supplementation and Weight Loss

Effect of Protein Supplementation on Weight Loss and Cardio Metabolic Profile of Overweight/Obese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: herbalife protein shake

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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: treament; herbalife protein shake along with exercise	Dietary supplement: herbalife protein shake
No Intervention: control; diet and exercise only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight loss	baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
improvement in lipid profile	baseline - 3 months

Collaborators and Investigators

• Sponsor: Diabetes Foundation, India

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Estimate): February 11, 2015
• Last Update Submitted That Met QC Criteria: February 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: herbalife.2014