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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562209
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Anoop Misra, Diabetes Foundation, India

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: PACER Diet Other: Standard weight reducing diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Determine the Effect of PACER Diet (High Protein Atkin's Complete VEgetaRian Diet) in Obese Subjects
Study Start Date : January 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Weight loss (kg) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Lipid profile [ Time Frame: 8 weeks ]
  2. Insulin resistance [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562209


Locations
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India
Fortis Flt Lt Rajan Dhall Hospital
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Diabetes Foundation, India
Investigators
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Principal Investigator: Anoop Misra, MD Diabetes Foundation, India
Publications:
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Responsible Party: Dr Anoop Misra, Dr. Anoop Misra, Diabetes Foundation, India
ClinicalTrials.gov Identifier: NCT02562209    
Other Study ID Numbers: PACER_2015
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by Dr Anoop Misra, Diabetes Foundation, India:
Obesity
Abdominal adiposity
High protein diet
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms