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Almonds and Cognitive Functions

Sponsor
Diabetes Foundation, India (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05322304
Collaborator
National Diabetes Obesity and Cholesterol Foundation (Other), Almond Board of California (Other)
60
Enrollment
2
Arms
29
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Almond
 N/A

Detailed Description

Objectives and Measurements:
  1. 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:

  1. Intervention group: Individualized diets incorporating almonds, 20% energy. Macronutrient composition: Carbohydrates,49%en., fats,32%en., and proteins, 19%en.
  1. Control group: Isocaloric diet. Macronutrient composition: Carbohydrates,50%en., fats, 35%en., proteins,15%en.

  1. The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
parallel arm randomized controlledparallel arm randomized controlled
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Randomized Controlled Trial of Almond Supplementation vs. Isocaloric Diet on Cognitive Functions in Middle-aged (40-60 Years) Asian Indians With Prediabetes
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: almond

dietary intervention with almonds ()20% of energy)

Dietary Supplement: Almond
Intervention (almond supplementation) and Isocaloric diets (control)
No Intervention: Control

usual diet and lifestyle

Outcome Measures

Primary Outcome Measures

  1. neuropsychological function [2 year]

    cognitive functions using computerized neuropsychological assessment systems (CANTAB

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Diabetes Foundation, India
  • National Diabetes Obesity and Cholesterol Foundation
  • Almond Board of California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Diabetes Foundation, India
ClinicalTrials.gov Identifier:
NCT05322304
Other Study ID Numbers:
  • NDOC.12/2022
First Posted:
Apr 11, 2022
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Diabetes Foundation, India
almonds
prediabetes
cognition
Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance

Study Results

No Results Posted as of Apr 11, 2022