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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: PACER Diet
* Other: Standard weight reducing diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACER diet<br>High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER Diet) to be followed for 8 weeks. | Dietary Supplement: PACER Diet<br>* Pacer diet to be followed for 8 weeks<br>|
| Active Comparator: Standard weight reducing diet<br>This group was prescribed Standard weight reducing diet to be followed for 8 weeks. | Other: Standard weight reducing diet<br>* Standard weight reducing diet to be followed for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss (kg) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile |  | 8 weeks | 
| Insulin resistance |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Abdominal adiposity, High protein diet