Effect of Raisins on Cognitive Function in Healthy Older Adults
Primary Purpose
Cognitive Dysfunction
Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Raisins
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Dysfunction focused on measuring Cognitive dysfunction, Heart Disease Risk Factors, Vitis, Polyphenols, Clinical Trial
Eligibility Criteria
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.
Sites / Locations
- José Ignacio Recio RodriguezRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Experimental group
Arm Description
No intervention
Supplementation of 50 g daily of rainsins for 3 months
Outcomes
Primary Outcome Measures
Cognitive impairment
Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). 30 (better score)
Secondary Outcome Measures
Health-related quality of life
Evaluated by EuroQoL-5D-3L (EuroQol Visual Analogue Scale (EQ-VAS)) Range 0-100. 100 (best quality of life)
Health-related quality of life
Evaluated by EuroQoL-5D-3L (EQ-5D summary index ) Range 0-1. 1 (best quality of life)
Health-related quality of life
Evaluated by WHOQOL-AGE. Total score Range 0-65. 65 (best quality of life)
Blood pressure
Measured in mmHg
Plasma cholesterol
Measured in mg/dL
Inflammatory marker (IL-6
Measured in pg/ml
Full Information
NCT ID
NCT04966455
First Posted
July 1, 2021
Last Updated
September 19, 2022
Sponsor
University of Salamanca
1. Study Identification
Unique Protocol Identification Number
NCT04966455
Brief Title
Effect of Raisins on Cognitive Function in Healthy Older Adults
Official Title
Effect of Supplementing the Diet With Raisins, a Food Rich in Polyphenols, on Cognitive Function in Healthy Older Adults, a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
Cognitive dysfunction, Heart Disease Risk Factors, Vitis, Polyphenols, Clinical Trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Supplementation of 50 g daily of rainsins for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Raisins
Intervention Description
Daily supplementation of 50 g of rainsins for 3 months
Primary Outcome Measure Information:
Title
Cognitive impairment
Description
Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). 30 (better score)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
Evaluated by EuroQoL-5D-3L (EuroQol Visual Analogue Scale (EQ-VAS)) Range 0-100. 100 (best quality of life)
Time Frame
3 months
Title
Health-related quality of life
Description
Evaluated by EuroQoL-5D-3L (EQ-5D summary index ) Range 0-1. 1 (best quality of life)
Time Frame
3 months
Title
Health-related quality of life
Description
Evaluated by WHOQOL-AGE. Total score Range 0-65. 65 (best quality of life)
Time Frame
3 months
Title
Blood pressure
Description
Measured in mmHg
Time Frame
3 months
Title
Plasma cholesterol
Description
Measured in mg/dL
Time Frame
3 months
Title
Inflammatory marker (IL-6
Description
Measured in pg/ml
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose I Recio-Rodriguez, PhD
Phone
0034 663176041
Email
donrecio@usal.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose I Recio-Rodriguez, PhD
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
José Ignacio Recio Rodriguez
City
Salamanca
ZIP/Postal Code
37005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Ignacio Recio Rodriguez, PhD
Phone
650330694
Email
donrecio@usal.es
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Raisins on Cognitive Function in Healthy Older Adults
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