NCT05322304

Almonds and Cognitive Functions

Randomized Controlled Trial of Almond Supplementation vs. Isocaloric Diet on Cognitive Functions in Middle-aged (40-60 Years) Asian Indians With Prediabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Diabetes Foundation, India · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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 1. This will be a randomized controlled parallel arm study on free living Asian Indians, selected based on inclusion criteria. 2. Sample size: 60 (n, 30 in each arm) 3. 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. 4. 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 5. 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. 6. The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance 7. 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: 1. Biweekly telephonic calls. During these telephonic calls compliance to diet, exercise, almond intake, adverse event or any problem with the intervention will be assessed. Calls will be recorded in a call log and subject compliance (consumption of almonds) will be recorded in the proforma. 2. Text messages reminding intake of almonds (weekly) and face-to-face interactions (once every month, at least 20 min each session) discussing problems if any.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Almond	Intervention (almond supplementation) and Isocaloric diets (control)

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-03-30
• Completion: 2024-08-30
• First posted: 2022-04-11
• Last updated: 2023-02-16

Locations

1 site across 1 country: India