Obesity
Conditions
Keywords
Obesity, Abdominal adiposity, High protein diet
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.
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
Sponsors
Diabetes Foundation, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss (kg) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile | 8 weeks |
| Insulin resistance | 8 weeks |
Countries
India
Outcome results
None listed