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Completed

NCT Number: NCT02144636

Protein Supplementation and Weight Loss

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Delhi, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

herbalife protein shake

Dietary Supplement

Primary outcomes

  1. weight loss

    Time frame: baseline to 3 months

Secondary outcomes

  1. improvement in lipid profile

    Time frame: baseline - 3 months

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
First posted
May 22, 2014
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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