Cognitive DysfunctionPhase 3NCT04966455
Effect of Raisins on Cognitive Function in Healthy Older Adults
A Phase 3 study testing Raisins in people with Cognitive Dysfunction, run by University of Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Raisins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2021to 20 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Raisins
- Keywords
- Cognitive dysfunction, Heart Disease Risk Factors, Vitis, Polyphenols, Clinical Trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaisinsDietary supplement
Daily supplementation of 50 g of rainsins for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention |
| Experimental group | Experimental | Supplementation of 50 g daily of rainsins for 3 months Receives: Dietary Supplement: Raisins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment
Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). 30 (better score)
Measured: 3 months
Secondary outcomes (6)
Health-related quality of life
Evaluated by EuroQoL-5D-3L (EuroQol Visual Analogue Scale (EQ-VAS)) Range 0-100. 100 (best quality of life)
Measured: 3 months
Health-related quality of life
Evaluated by EuroQoL-5D-3L (EQ-5D summary index ) Range 0-1. 1 (best quality of life)
Measured: 3 months
Health-related quality of life
Evaluated by WHOQOL-AGE. Total score Range 0-65. 65 (best quality of life)
Measured: 3 months
Blood pressure
Measured in mmHg
Measured: 3 months
Plasma cholesterol
Measured in mg/dL
Measured: 3 months
Inflammatory marker (IL-6
Measured in pg/ml
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start20 Sep 2021
- Primary completion20 Apr 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Ignacio Recio Rodriguez, University of Salamanca
- Investigators
- Jose I Recio-Rodriguez, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966455
- Sponsor's protocol ID
- GRS 2381/A/21
- Status last verified
- Dec 2023
- First submitted
- 1 Jul 2021
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36991396
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04966455
- Acronym / sponsor ID
- GRS 2381/A/21
- Conditions
- Cognitive Dysfunction
- Keywords
- Cognitive dysfunction, Heart Disease Risk Factors, Vitis, Polyphenols, Clinical Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention |
| Experimental group | Experimental | Dietary Supplement: RaisinsSupplementation of 50 g daily of rainsins for 3 months |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaisinsDaily supplementation of 50 g of rainsins for 3 months | Dietary supplement | Experimental group |
Primary outcome
Cognitive impairment
Time frame: 3 months
Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). 30 (better score)
6 secondary outcomes
Health-related quality of life
Time frame: 3 months
Health-related quality of life
Time frame: 3 months
Health-related quality of life
Time frame: 3 months
Blood pressure
Time frame: 3 months
Plasma cholesterol
Time frame: 3 months
Inflammatory marker (IL-6
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Derived from this study: PubMed 36991396Rodrigo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose I Recio-Rodriguez, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Raisins in people with Cognitive Dysfunction, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04966455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.