Almonds and Cognitive Functions

Diabetes Foundation, India

Status: Enrolling

Conditions: PreDiabetes

Treatments: Dietary Supplement: Almond

Study type: Interventional

Funder types: Other

Identifiers

NCT05322304

NDOC.12/2022

Details and patient eligibility

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:

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. 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

almond

Experimental group

Description:

dietary intervention with almonds ()20% of energy)

Treatment:

Dietary Supplement: Almond

Control

No Intervention group

Description:

usual diet and lifestyle