Effect of Raisins on Cognitive Function in Healthy Older Adults

NCT04966455 | Completed Phase 3

• 1 other identifier: GRS 2381/A/21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cognitive Dysfunction

Keywords

Cognitive dysfunction; Heart Disease Risk Factors; Vitis; Polyphenols; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Cognitive impairment

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

  3 months

Secondary Outcomes (6)

• Health-related quality of life

  3 months

• Health-related quality of life

  3 months

• Health-related quality of life

  3 months

• Blood pressure

  3 months

• Plasma cholesterol

  3 months

Study Arms (2)

Control group

NO INTERVENTION

No intervention

Experimental group

EXPERIMENTAL

Supplementation of 50 g daily of rainsins for 3 months

Dietary Supplement: Raisins

Interventions

Raisins DIETARY_SUPPLEMENT

Daily supplementation of 50 g of rainsins for 3 months

Experimental group

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

José Ignacio Recio Rodriguez

Salamanca, 37005, Spain

Location

Related Publications (1)

• 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.

  PMID: 36991396 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jose I Recio-Rodriguez, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Biosciences, Principal Investigator

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 19, 2021
• Study Start: September 20, 2021
• Primary Completion: April 20, 2023
• Study Completion: May 20, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)