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| Name | Class |
|---|---|
| National Diabetes Obesity and Cholesterol Foundation | OTHER |
| Almond Board of California | OTHER |
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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).
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
This will be a randomized controlled parallel arm study on free living Asian Indians, selected based on inclusion criteria.
Sample size: 60 (n, 30 in each arm)
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.
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
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.
The diet (as above) and lifestyle modification will be continued in both groups for 6 months with rigorous compliance
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| almond | Experimental | dietary intervention with almonds ()20% of energy) |
|
| Control | No Intervention | usual diet and lifestyle |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almond | Dietary Supplement | Intervention (almond supplementation) and Isocaloric diets (control) |
|
| Measure | Description | Time Frame |
|---|---|---|
| neuropsychological function | cognitive functions using computerized neuropsychological assessment systems (CANTAB | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anoop Misra, MD | Contact | 011-41759672 | 103 | anoopmisra@gmail.com |
| Seema Gulati, Ph.d | Contact | 011-41759672 | 102 | seemagulati2007@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Diabetes Obesity and cholesterol Foundation (NDOC) | Recruiting | Delhi | 110024 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41850683 | Derived | Gulati S, Misra A, Tiwari R, Pandey RM, Sharma M. Effects of 24-Week Almond Supplementation on Executive Function and Processing Speed in Middle-Aged Asian Indians with Prediabetes: An Open-Label Randomized Controlled Trial. J Nutr. 2026 May;156(5):101484. doi: 10.1016/j.tjnut.2026.101484. Epub 2026 Mar 16. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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parallel arm randomized controlled
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| D004700 | Endocrine System Diseases |