NCT02144636

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

May 20, 2014

Last Update Submit

February 10, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

    baseline to 3 months

Secondary Outcomes (1)

  • improvement in lipid profile

    baseline - 3 months

Study Arms (2)

treament

EXPERIMENTAL

herbalife protein shake along with exercise

Dietary Supplement: herbalife protein shake

control

NO INTERVENTION

diet and exercise only

Interventions

herbalife protein shakeDIETARY_SUPPLEMENT
treament

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged between 21 -65 years
  • Subjects with BMI \> 23 Kg/m2

You may not qualify if:

  • Subjects aged between 21 -65 years
  • Subjects with BMI \> 23 Kg/m2
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Delhi, India

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

November 1, 2012

Primary Completion

October 1, 2014

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

IN(1)