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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 October 2015
• Main ID: NCT02562209
• Date of registration: 26/09/2015
• Prospective Registration: No
• Primary sponsor: Diabetes Foundation, India
• Public title: High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER) and Weight Loss PACER
• Scientific title: To Determine the Effect of PACER Diet (High Protein Atkin's Complete VEgetaRian Diet) in Obese Subjects
• Date of first enrolment: January 2012
• Target sample size: 104
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02562209
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Anoop Misra, MD
• Affiliation: Diabetes Foundation, India

Key inclusion & exclusion 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



Age minimum: 25 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Dietary Supplement: PACER Diet

Other: Standard weight reducing diet

Primary Outcome(s)

Weight loss (kg) [Time Frame: 8 weeks]

Secondary Outcome(s)

Insulin resistance [Time Frame: 8 weeks]

Lipid profile [Time Frame: 8 weeks]

Secondary ID(s)

PACER_2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors