Almonds and Cognitive Functions

February 14, 2023 updated by: Diabetes Foundation, India

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Delhi, India, 110024
        • Recruiting
        • National Diabetes Obesity and cholesterol Foundation (NDOC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anoop Misra, MD
        • Sub-Investigator:
          • Seema Gulati, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuropsychological function
Time Frame: 2 year
cognitive functions using computerized neuropsychological assessment systems (CANTAB
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes Foundation, India

Collaborators

Almond Board of California
National Diabetes Obesity and Cholesterol Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

March 30, 2024

Study Completion (Anticipated)

August 30, 2024

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

April 3, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDOC.12/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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