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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322304
• Other study ID #: NDOC.12/2022
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2023
• Source: Diabetes Foundation, India
• Contact: Anoop Misra, MD
• Phone: 011-41759672
• Email: anoopmisra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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)

2. age 40-60 years

Exclusion Criteria:

1. Subjects Having Inability to Undergo Neuropsychological Testing

2. Previously Diagnosed Neurodegenerative Disease Prior Stroke

3. Significant Head Trauma, or Brain Surgery

4. Relevant Psychiatric Illness

5. Major Depression

6. Morbid Obesity

7. Diabetes

8. Uncontrolled Hypertension

9. Prior Chemotherapy

10. Allergy to Almonds

11. Habitual Consumption of Tree nuts (>2 Servings/Wk.); or Customary Use Of Fish Oil, Flaxseed Oil, and/ Or Soy Lecithin

12. Chronic Smoking

13. Alcohol abuse (> 2 Drinks, 60 Ml Of Whisky Per Day)

14. Severe Dyslipidemia (Total Cholesterol > 300 Mg/Dl, Serum Triglycerides > 500mg/Dl)

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Almond
Intervention (almond supplementation) and Isocaloric diets (control)

Locations

Country	Name	City	State
India	National Diabetes Obesity and cholesterol Foundation (NDOC)	Delhi

Sponsors (3)

Lead Sponsor	Collaborator
Diabetes Foundation, India	Almond Board of California, National Diabetes Obesity and Cholesterol Foundation

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropsychological function	cognitive functions using computerized neuropsychological assessment systems (CANTAB	2 year