Clinical trial NCT05322304: Almonds and Cognitive Functions
Official title: Randomized Controlled Trial of Almond Supplementation vs. Isocaloric Diet on Cognitive Functions in Middle-aged (40-60 Years) Asian Indians With Prediabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Keywords: almonds
prediabetes
cognition
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
Collaborators: name: National Diabetes Obesity and Cholesterol Foundation
name: Almond Board of California
First posted: 2022-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel arm randomized controlled
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: neuropsychological function
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Delhi
country: India
facility: National Diabetes Obesity and cholesterol Foundation (NDOC)
Study officials:
References: