Status:

UNKNOWN

Almonds and Cognitive Functions

Lead Sponsor:

Diabetes Foundation, India

Collaborating Sponsors:

National Diabetes Obesity and Cholesterol Foundation

Almond Board of California

Conditions:

PreDiabetes

Eligibility:

All Genders

40-60 years

Phase:

NA

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 ye...

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 t...

Eligibility Criteria

Inclusion

  • 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)
  • age 40-60 years

Exclusion

  • Subjects Having Inability to Undergo Neuropsychological Testing
  • Previously Diagnosed Neurodegenerative Disease Prior Stroke
  • Significant Head Trauma, or Brain Surgery
  • Relevant Psychiatric Illness
  • Major Depression
  • Morbid Obesity
  • Diabetes
  • Uncontrolled Hypertension
  • Prior Chemotherapy
  • Allergy to Almonds
  • Habitual Consumption of Tree nuts (\>2 Servings/Wk.); or Customary Use Of Fish Oil, Flaxseed Oil, and/ Or Soy Lecithin
  • Chronic Smoking
  • Alcohol abuse (\> 2 Drinks, 60 Ml Of Whisky Per Day)
  • Severe Dyslipidemia (Total Cholesterol \> 300 Mg/Dl, Serum Triglycerides \> 500mg/Dl)

Key Trial Info

Start Date :

June 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 30 2024

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05322304

Start Date

June 1 2022

End Date

August 30 2024

Last Update

February 16 2023

Active Locations (1)

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1

National Diabetes Obesity and cholesterol Foundation (NDOC)

Delhi, India, 110024