Clinical trial NCT02562209: High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER) and Weight Loss
Official title: To Determine the Effect of PACER Diet (High Protein Atkin's Complete VEgetaRian Diet) in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Abdominal adiposity
High protein diet
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 104
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss (kg)
timeFrame: 8 weeks
Secondary outcomes:
measure: Lipid profile
timeFrame: 8 weeks
measure: Insulin resistance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Fortis Flt Lt Rajan Dhall Hospital
state: Delhi
Study officials:
affiliation: Diabetes Foundation, India
name: Anoop Misra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.