Almonds and Cognitive Functions
Randomized Controlled Trial of Almond Supplementation vs. Isocaloric Diet on Cognitive Functions in Middle-aged (40-60 Years) Asian Indians With Prediabetes
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedFebruary 16, 2023
February 1, 2023
1.8 years
March 25, 2022
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
neuropsychological function
cognitive functions using computerized neuropsychological assessment systems (CANTAB
2 year
Study Arms (2)
almond
EXPERIMENTALdietary intervention with almonds ()20% of energy)
Control
NO INTERVENTIONusual diet and lifestyle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diabetes Foundation, Indialead
- National Diabetes Obesity and Cholesterol Foundationcollaborator
- Almond Board of Californiacollaborator
Study Sites (1)
National Diabetes Obesity and cholesterol Foundation (NDOC)
Delhi, 110024, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2022
First Posted
April 11, 2022
Study Start
June 1, 2022
Primary Completion
March 30, 2024
Study Completion
August 30, 2024
Last Updated
February 16, 2023
Record last verified: 2023-02