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Completed

NCT Number: NCT04966455

Effect of Raisins on Cognitive Function in Healthy Older Adults

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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Key information

Age range

70 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

José Ignacio Recio Rodriguez

Salamanca, 37005, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People of both sexes aged between 70 and 80 years.
  • 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

  • Coronary or cerebrovascular atherosclerotic pathology.
  • 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.

Treatment and study plan

Raisins

Dietary Supplement

Daily supplementation of 50 g of rainsins for 3 months

Primary outcomes

  1. Cognitive impairment

    Time frame: 3 months

    Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). 30 (better score)

Secondary outcomes

  1. Health-related quality of life

    Time frame: 3 months

    Evaluated by EuroQoL-5D-3L (EuroQol Visual Analogue Scale (EQ-VAS)) Range 0-100. 100 (best quality of life)

  2. Health-related quality of life

    Time frame: 3 months

    Evaluated by EuroQoL-5D-3L (EQ-5D summary index ) Range 0-1. 1 (best quality of life)

  3. Health-related quality of life

    Time frame: 3 months

    Evaluated by WHOQOL-AGE. Total score Range 0-65. 65 (best quality of life)

  4. Blood pressure

    Time frame: 3 months

    Measured in mmHg

  5. Plasma cholesterol

    Time frame: 3 months

    Measured in mg/dL

  6. Inflammatory marker (IL-6

    Time frame: 3 months

    Measured in pg/ml

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

Effect of Supplementing the Diet With Raisins, a Food Rich in Polyphenols, on Cognitive Function in Healthy Older Adults, a Randomised Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2021
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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