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Completed

NCT Number: NCT02562209

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

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fortis Flt Lt Rajan Dhall Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PACER Diet

Dietary Supplement

Pacer diet to be followed for 8 weeks

Standard weight reducing diet

Other

Standard weight reducing diet to be followed for 8 weeks

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

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Registry information

Official study title

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

Acronym: PACER

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2015
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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