Almonds and Cognitive Functions

PreDiabetes Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

• NCT number: NCT05322304
• Study type: Interventional
• Source: Diabetes Foundation, India
• Contact: Anoop Misra, MD
• Phone: 011-41759672
• Email: anoopmisra@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Completion date: August 30, 2024