Protein Supplementation and Weight Loss

Diabetes Foundation, India

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: herbalife protein shake

Study type

Interventional

Funder types

Other

Identifiers

NCT02144636

herbalife.2014

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects aged between 21 -65 years
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:

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