NCT02562209

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2012

Typical duration 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

January 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

September 26, 2015

Last Update Submit

September 28, 2015

Conditions

Obesity

Keywords

ObesityAbdominal adiposityHigh protein diet

Outcome Measures

Primary Outcomes (1)

  • Weight loss (kg)

    8 weeks

Secondary Outcomes (2)

  • Lipid profile

    8 weeks

  • Insulin resistance

    8 weeks

Study Arms (2)

PACER diet

EXPERIMENTAL

High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER Diet) to be followed for 8 weeks.

Dietary Supplement: PACER Diet

Standard weight reducing diet

ACTIVE COMPARATOR

This group was prescribed Standard weight reducing diet to be followed for 8 weeks.

Other: Standard weight reducing diet

Interventions

PACER DietDIETARY_SUPPLEMENT

Pacer diet to be followed for 8 weeks

PACER diet
Standard weight reducing dietOTHER

Standard weight reducing diet to be followed for 8 weeks

Standard weight reducing diet

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortis Flt Lt Rajan Dhall Hospital

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (2)

  • Bhardwaj S, Misra A. Obesity, diabetes and the Asian phenotype. World Rev Nutr Diet. 2015;111:116-22. doi: 10.1159/000362308. Epub 2014 Nov 17. No abstract available.

    PMID: 25418400BACKGROUND

  • Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Greaves KA, Paul G, Singer W. The effect of a plant-based low-carbohydrate ("Eco-Atkins") diet on body weight and blood lipid concentrations in hyperlipidemic subjects. Arch Intern Med. 2009 Jun 8;169(11):1046-54. doi: 10.1001/archinternmed.2009.115.

    PMID: 19506174BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anoop Misra, MD

    Diabetes Foundation, India

    PRINCIPAL INVESTIGATOR

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
Dr. Anoop Misra

Study Record Dates

First Submitted

September 26, 2015

First Posted

September 29, 2015

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

IN(1)