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CompletedNCT02562209PACERUpdated Sep 29, 2015

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

An interventional study of PACER Diet and Standard weight reducing diet in Obesity, sponsored by Diabetes Foundation, India. Completed at 1 site in India. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-09-29.

Sponsored by Diabetes Foundation, India · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Abdominal adiposity
  • High protein diet
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 104 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Diabetes Foundation, India is the lead sponsor of 29 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Experimental
    PACER diet

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

    Dietary Supplement: PACER Diet

  • 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

Interventions

  • Dietary supplementPACER Diet

    Pacer diet to be followed for 8 weeks

  • OtherStandard weight reducing diet

    Standard weight reducing diet to be followed for 8 weeks

06

What researchers measure

Primary outcomes

  1. Weight loss (kg)

    Time frame: 8 weeks

Secondary outcomes

  1. Lipid profile

    Time frame: 8 weeks

  2. Insulin resistance

    Time frame: 8 weeks

07

Study locations

1 site
  • Fortis Flt Lt Rajan Dhall Hospital
    New Delhi, Delhi 110070, India
08

References and documents

Publications

  • 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. PubMed 25418400 ↗
  • 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. Erratum In: Arch Intern Med. 2009 Sep 14;169(16):1490. PubMed 19506174 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02562209
Lead sponsor
Diabetes Foundation, India
Responsible party
Dr Anoop Misra (Dr. Anoop Misra, Diabetes Foundation, India) — Principal investigator
First posted
Sep 29, 2015
Start date
Jan 2012
Primary completion
Jun 2014
Completion
Nov 2014
Last update
Sep 29, 2015

Study contacts

Anoop Misra, MD
principal investigator · Diabetes Foundation, India

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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