Protein Supplementation and Weight Loss

NCT ID: NCT02144636

Last Updated: 2015-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treament

herbalife protein shake along with exercise

Group Type EXPERIMENTAL

herbalife protein shake

Intervention Type DIETARY_SUPPLEMENT

control

diet and exercise only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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herbalife protein shake

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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


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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Diabetes Foundation, India

OTHER

Sponsor Role lead

Responsible Party

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Dr Anoop Misra

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Delhi, , India

Site Status

Countries

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India

Other Identifiers

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herbalife.2014

Identifier Type: -

Identifier Source: org_study_id

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