High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER) and Weight Loss (PACER)

September 28, 2015 updated by: Dr Anoop Misra, Diabetes Foundation, India

To Determine the Effect of PACER Diet (High Protein Atkin's Complete VEgetaRian Diet) in Obese Subjects

This study evaluates the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Increasing the protein consumption promotes weight loss through several mechanisms. Diets high in protein promote energy expenditure through increased postprandial thermogenesis, increase total daily expenditure and increase satiety as compared to carbohydrate. The present study aims to evaluate the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Fortis Flt Lt Rajan Dhall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Age 25 to 60 years
  • Body mass index (BMI) ≥ 25 kg/m2 to 40 kg/m2
  • Subjects who have stable weight, i.e. who have not had more than ± 3 kg variation in their weight level in the 3 months prior to screening for this study.
  • Absence of significant disease or clinically significant medical history or physical examination during screening in the view of the investigator.
  • Subjects willing to provide written inform consent to participate in the study.

Exclusion Criteria

  • Body mass index (BMI) > 40 kg/m2
  • Any patient taking/requiring drugs known to effect insulin resistance, lipids, vascular reactivity, during the intervention period would be excluded from the study
  • Patients on any drugs that change the weight or in conditions where dietary protein supplementation is contraindicated
  • Subjects who are consuming a high protein diet on randomization, to be excluded
  • Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc
  • Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs
  • Pregnancy & lactation

  • Patients having diagnosed with any of the following:

    • Type 2 diabetes mellitus
    • Cushing's disease
    • Severe end organ damage
  • Unwillingness to give written informed consent for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PACER diet
High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER Diet) to be followed for 8 weeks.
Dietary supplement: PACER Diet
Pacer diet to be followed for 8 weeks
Active Comparator: Standard weight reducing diet
This group was prescribed Standard weight reducing diet to be followed for 8 weeks.
Other: Standard weight reducing diet
Standard weight reducing diet to be followed for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss (kg)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Lipid profile
Time Frame: 8 weeks
8 weeks
Insulin resistance
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes Foundation, India

Investigators

  • Principal Investigator: Anoop Misra, MD, Diabetes Foundation, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 26, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACER_2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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