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Objective:To assess the effect of an intervention based on including 50 g of raisins (sultanas) daily in the diet for 3 months on improving cognitive performance, cardiovascular risk factors and inflammatory markers in a population of older adults without cognitive impairment.
Methodology: Randomised two parallel-group clinical trial. Population: 80 patients between 70 and 80 years of age will be included, selected from primary care clinics in Salamanca and Zamora.
Measurements and intervention: Participants included in the study will have a baseline visit and two evaluations visits at 3 and 6 months where cognitive performance (attention, executive functions, verbal memory, working memory and language) will be assessed using a brief neuropsychological battery; quality of life, using the WHOQol- AGE and EUROQOL-5D questionnaire; blood pressure; glycaemia; body composition, using an impedancemeter; and different markers of inflammation, interleukin (IL) 6, IL-1 and tumour necrosis factor alpha (TNF); and different markers of inflammation, interleukin (IL) 6, IL-1 and tumour necrosis factor alpha (TNF-α).
Participants will be randomised using the Epidat 4.0 programme into 2 groups (control group and intervention group) with a ratio of 1:1. Both groups will be instructed to continue with their usual dietary pattern without changing their habits during the study period.
Those in the control group will not receive any amount of raisins to their usual diet. The participants in the intervention group will receive 50 g of raisins and instructions on the time of day to take it (at night). The duration of this intervention will be 3 months. The daily nutritional intake of this amount of raisins is as follows: 146 kcal; 0.25 g of fat; 34 g carbohydrates of which 34 g sugars; 1.3 g protein; 1 g fibre. The total polyphenol content of total polyphenols from 50 g of raisinas is approximately 532,5 mg (phenols explorer database).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | No intervention | |
| Experimental group | Experimental | Supplementation of 50 g daily of rainsins for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raisins | Dietary Supplement | Daily supplementation of 50 g of rainsins for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive impairment | Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). 30 (better score) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | Evaluated by EuroQoL-5D-3L (EuroQol Visual Analogue Scale (EQ-VAS)) Range 0-100. 100 (best quality of life) | 3 months |
| Health-related quality of life | Evaluated by EuroQoL-5D-3L (EQ-5D summary index ) Range 0-1. 1 (best quality of life) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose I Recio-Rodriguez, PhD | University of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| José Ignacio Recio Rodriguez | Salamanca | 37005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36991396 | Derived | Rodrigo-Gonzalo MJ, Recio-Rodriguez JI, Mendez-Sanchez R, Pablos-Hernandez MC, Gonzalez-Ramirez A, Gonzalez-Sanchez J, Fermoso-Palmero MJ, Puente-Gonzalez AS, Sanchez-Sanchez MC, Barbero-Iglesias FJ, Rihuete-Galve MI, Gonzalez-Manzano S. Effect of including a dietary supplement of raisins, a food rich in polyphenols, on cognitive function in healthy older adults; a study protocol for a randomized clinical trial. BMC Geriatr. 2023 Mar 29;23(1):182. doi: 10.1186/s12877-023-03882-6. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 3 months |
| Health-related quality of life | Evaluated by WHOQOL-AGE. Total score Range 0-65. 65 (best quality of life) | 3 months |
| Blood pressure | Measured in mmHg | 3 months |
| Plasma cholesterol | Measured in mg/dL | 3 months |
| Inflammatory marker (IL-6 | Measured in pg/ml | 3 months |