Effect of Raisins on Cognitive Function in Healthy Older Adults
NCT ID: NCT04966455
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2021-09-20
2023-05-20
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control group
No intervention
No interventions assigned to this group
Experimental group
Supplementation of 50 g daily of rainsins for 3 months
Raisins
Daily supplementation of 50 g of rainsins for 3 months
Interventions
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Raisins
Daily supplementation of 50 g of rainsins for 3 months
Eligibility Criteria
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Inclusion Criteria
* The score on the Mini Mental State Examination (MMSE) must be greater than or equal to 24 points.
* Self-employed to attend the centre where the study is carried out.
* Signature of the informed consent form.
Exclusion Criteria
* Diabetes mellitus
* Grade II or higher heart failure.
* Moderate or severe chronic obstructive pulmonary disease.
* Advanced renal or hepatic disease.
* Severe mental illness.
* Oncological disease under treatment diagnosed within the last 5 years or terminal condition.
* Morbid obesity (IMC ≥ 40 kg/m2).
* Intolerance and/or allergy to any of the grape components.
* Any other circumstance at the criterion of the researchers.
70 Years
80 Years
ALL
Yes
Sponsors
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University of Salamanca
OTHER
Responsible Party
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José Ignacio Recio Rodriguez
PhD in Biosciences, Principal Investigator
Principal Investigators
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Jose I Recio-Rodriguez, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Salamanca
Locations
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José Ignacio Recio Rodriguez
Salamanca, , Spain
Countries
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References
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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.
Other Identifiers
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GRS 2381/A/21
Identifier Type: -
Identifier Source: org_study_id