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Protein Supplementation and Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
herbalife protein shake
Sponsored by
Diabetes Foundation, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treament

control

Arm Description

herbalife protein shake along with exercise

diet and exercise only

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

improvement in lipid profile

Full Information

First Posted
May 20, 2014
Last Updated
February 10, 2015
Sponsor
Diabetes Foundation, India
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1. Study Identification

Unique Protocol Identification Number
NCT02144636
Brief Title
Protein Supplementation and Weight Loss
Official Title
Effect of Protein Supplementation on Weight Loss and Cardio Metabolic Profile of Overweight/Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diabetes Foundation, India

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treament
Arm Type
Experimental
Arm Description
herbalife protein shake along with exercise
Arm Title
control
Arm Type
No Intervention
Arm Description
diet and exercise only
Intervention Type
Dietary Supplement
Intervention Name(s)
herbalife protein shake
Primary Outcome Measure Information:
Title
weight loss
Time Frame
baseline to 3 months
Secondary Outcome Measure Information:
Title
improvement in lipid profile
Time Frame
baseline - 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects aged between 21 -65 years Subjects with BMI > 23 Kg/m2 Exclusion Criteria: Inclusion Criteria: Subjects aged between 21 -65 years Subjects with BMI > 23 Kg/m2 Exclusion Criteria: Diabetes (type 1 and type 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) Angina or other chest pain that may indicate CHD by history Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable) by history 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 Pregnancy or planning pregnancy during the study period by history Uncontrolled hypertension Uncontrolled hypothyroidism Sensitivity or allergy to product by history Subjects who had undergone bypass procedure Any debilitating disease such as tuberculosis, HIV by history . Unwillingness to give written informed consent for participation in the study
Facility Information:
Facility Name
Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology
City
Delhi
Country
India

12. IPD Sharing Statement

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