Status
Conditions
Treatments
About
Initial Recruitment and Sensitization: In this free-living randomized control parallel arm study of 24 weeks of almond intervention, we shall recruit apparently healthy middle aged (age range 40-60 years)prediabetic Asian Indians having fasting blood glucose ≥100mg/dl and <126 mg/dl and /or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75-gram anhydrous oral glucose).
Full description
Objectives and Measurements:
a. Primary Objective: To evaluate the effect of almond supplementation on cognitive functions Co-primary Objective: To evaluate changes in neuroimaging (blood flow, and the expression of functional brain networks during cognitive demands) using functional MRI.
Flow of Study Procedures
This will be a randomized controlled parallel arm study on free living Asian Indians, selected based on inclusion criteria.
Sample size: 60 (n, 30 in each arm)
After recruitment subjects would enter the run-in period for 2 weeks when they would be given standard diet and lifestyle modification counseling formulated according to guidelines for Asian Indians.
Subjects would be screened again just for inclusion/exclusion criteria at the end of the run-in period and would be randomized either to the experimental group or control group
Composition of diets:
i. Intervention group: Individualized diets incorporating almonds, 20% energy. Macronutrient composition: Carbohydrates,49%en., fats,32%en., and proteins, 19%en.
ii. Control group: Isocaloric diet. Macronutrient composition: Carbohydrates,50%en., fats, 35%en., proteins,15%en.
The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance
Compliance Checks: The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance check .
Compliance for the intervention in all the subjects (control and intervention group) will be checked by taking following measures:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Loading...
Central trial contact
Anoop Misra, MD; Seema Gulati, Ph.d
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal