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Clinical Trials/NCT02144636
NCT02144636
Completed
Not Applicable

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

Diabetes Foundation, India1 site in 1 country100 target enrollmentNovember 2012
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ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Diabetes Foundation, India
Enrollment
100
Locations
1
Primary Endpoint
weight loss
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Anoop Misra

Director

Diabetes Foundation, India

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

Outcomes

Primary Outcomes

weight loss

Time Frame: baseline to 3 months

Secondary Outcomes

  • improvement in lipid profile(baseline - 3 months)

Study Sites (1)

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