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

Diabetes Foundation, India

Status: Completed

Conditions: Obesity

Treatments: Other: Standard weight reducing diet; Dietary Supplement: PACER Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02562209

PACER_2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

104 participants in 2 patient groups

PACER diet

Experimental group

Description:

High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER Diet) to be followed for 8 weeks.

Treatment:

Dietary Supplement: PACER Diet

Standard weight reducing diet

Active Comparator group

Description:

This group was prescribed Standard weight reducing diet to be followed for 8 weeks.

Treatment:

Other: Standard weight reducing diet