CognitionNCT01411631
A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
A study testing Grape juice polyphenols in people with Cognition, run by University of Leeds at 1 site in United Kingdom.
Trial summary
There is some evidence that polyphenols can affect cognitive function. Therefore, consumption of polyphenols has the potential to prevent cognitive impairment or even enhance cognitive performance. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Grape juice polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Jun 2012
- Phase
- Interventional
- 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 40 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI within normal/overweight range (18 - 29 kg/m2)
- Non-smokers or given up more than 6 months ago
- Working 80% of a full time week (at least 30 hours/week)
- Ability to adequately understand verbal and written information in English
- Full Driving Licence held for at least 5 years
- Mothers of pre-teen children (must have child aged <13 years)
- Willing to abstain from drinking red wine and dark fruit juices (e.g. other grape juices, cranberry, raspberry and pomegranate juices) during the study
Who cannot join
- Menopausal
- diabetes or known impaired glucose tolerance
- taking any regular medication e.g. for hypertension
- Food allergies to ingredients and food colouring of the drinks to be consumed within the study
- Night shift work
- Pregnant or planning a pregnancy within the next year
Show all 11Show fewer
- Having been pregnant or lactating within the previous 6 months
- Vegetarian
- No history of, or current eating disorders
- Epilepsy (driving SIM exclusion criterion)
- Claustrophobia (driving SIM exclusion criterion)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds, Institute of Psychological Sciences
Leeds, West Yorkshire, LS29JT
About this study
There is some evidence that polyphenols can affect cognitive function. Therefore, consumption of polyphenols has the potential to prevent cognitive impairment or even enhance cognitive performance. The objective of this study is to investigate the effect of polyphenol consumption served in the form of Concord Grape Juice (CGJ) on cognitive performance and driving performance in Mums.
The study design will be a repeated measures, double-blind, randomised, placebo controlled, crossover study. There will be 2 conditions; CGJ and a placebo drink. 20 participants will undergo two 12 week dietary interventions which will entail daily consumption of a 12oz serving of CGJ or placebo in a counterbalanced manner. There will be a 4 week washout period between conditions. At baseline, 6, and 12 weeks of each 12-week treatment arm cognitive performance and driving performance will be assessed (using the driving simulator at the Institute for Transport Studies). CGJ is a common ingredient in commercially available products.
Mums will be defined as mothers of pre-teen children (aged under 13 years) who are aged 40-50. This population generally have hectic and stressful lifestyles and therefore there is potential for this population to receive cognitive benefit from polyphenol consumption.
- Conditions
- Cognition
- Being tested
- Grape juice polyphenols
- Keywords
- Polyphenols, Cognition, Cognitive function, Driving performance, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape juice polyphenolsDietary supplement
Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Grape juice | Active comparator | Participants will drink 100% concord grape juice daily for 12 weeks Receives: Dietary Supplement: Grape juice polyphenols |
| Placebo drink | Placebo comparator | Participants will drink the placebo for 12 weeks. The placebo will be equicaloric and matched on appearance, taste, volume and macronutrient composition to the grape juice drink. Receives: Dietary Supplement: Grape juice polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive function & Driving Performance
Cogntive function will be assessed with a battery of cognitive tests, including tests of memory, problem solving skills, concentration, and attention. Driving performance will be assessed using a driving simulator.
Measured: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Secondary outcomes (3)
Blood Pressure
Blood pressure measures will be taken over a period before, during and after the driving tasks using an ambulatory blood pressure monitor. An Omron M7 ambulatory blood pressure monitor will be used and can be worn during the driving task.
Measured: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Subjective Stress
The sample will be characterised in terms of their psychological stress using the Perceived Stress Scale (PSS, Cohen et al., 1983) the Cook-Medley Hostility Scale (Cook \& Medley, 1954), and the Spielberger STAI (Spielberger, 1983) administeredat screening. The PSS and the Spielberger MSTAI will also be administered on each test day.
Measured: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Subjective ratings of appetite, mood, mental alertness, and concentration
Measured using visual analogue scales a regular intervals throughout the test day.
Measured: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
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 CognitionStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Welch's, Inc.
- Responsible party
- Principal investigator, Prof Louise Dye, University of Leeds
- Investigators
- Louise Dye, PhD (Professor), Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411631
- Sponsor's protocol ID
- 11-0026
- Status last verified
- May 2014
- First submitted
- 7 Jun 2011
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lamport DJ, Lawton CL, Merat N, Jamson H, Myrissa K, Hofman D, Chadwick HK, Quadt F, Wightman JD, Dye L. Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children. Am J Clin Nutr. 2016 Mar;103(3):775-83. doi: 10.3945/ajcn.115.114553. Epub 2016 Feb 10.
PubMed 26864371
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effect of Concord Grape Juice on Cognitive Function in Mums of Preteen Children
- ClinicalTrials.gov ID
- NCT01411631
- Acronym / sponsor ID
- 11-0026
- Conditions
- Cognition
- Keywords
- Polyphenols, Cognition, Cognitive function, Driving performance, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Welch's, Inc.
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Aug 2011 (estimated)
- 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.
There is some evidence that polyphenols can affect cognitive function. Therefore, consumption of polyphenols has the potential to prevent cognitive impairment or even enhance cognitive performance. The objective of this study is to investigate the effect of polyphenol consumption served in the form of Concord Grape Juice (CGJ) on cognitive performance and driving performance in Mums.
The study design will be a repeated measures, double-blind, randomised, placebo controlled, crossover study. There will be 2 conditions; CGJ and a placebo drink. 20 participants will undergo two 12 week dietary interventions which will entail daily consumption of a 12oz serving of CGJ or placebo in a counterbalanced manner. There will be a 4 week washout period between conditions. At baseline, 6, and 12 weeks of each 12-week treatment arm cognitive performance and driving performance will be assessed (using the driving simulator at the Institute for Transport Studies). CGJ is a common ingredient in commercially available products.
Mums will be defined as mothers of pre-teen children (aged under 13 years) who are aged 40-50. This population generally have hectic and stressful lifestyles and therefore there is potential for this population to receive cognitive benefit from polyphenol consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grape juice | Active comparator | Dietary Supplement: Grape juice polyphenolsParticipants will drink 100% concord grape juice daily for 12 weeks |
| Placebo drink | Placebo comparator | Dietary Supplement: Grape juice polyphenolsParticipants will drink the placebo for 12 weeks. The placebo will be equicaloric and matched on appearance, taste, volume and macronutrient composition to the grape juice drink. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI within normal/overweight range (18 - 29 kg/m2)
- Non-smokers or given up more than 6 months ago
- Working 80% of a full time week (at least 30 hours/week)
- Ability to adequately understand verbal and written information in English
- Full Driving Licence held for at least 5 years
Key exclusion criteria (11 listed)
- Menopausal
- diabetes or known impaired glucose tolerance
- taking any regular medication e.g. for hypertension
- Food allergies to ingredients and food colouring of the drinks to be consumed within the study
- Night shift work
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 |
|---|---|---|
| Grape juice polyphenolsParticipants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks. | Dietary supplement | Grape juice, Placebo drink |
Primary outcome
Change in Cognitive function & Driving Performance
Time frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Cogntive function will be assessed with a battery of cognitive tests, including tests of memory, problem solving skills, concentration, and attention. Driving performance will be assessed using a driving simulator.
3 secondary outcomes
Blood Pressure
Time frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Subjective Stress
Time frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
Subjective ratings of appetite, mood, mental alertness, and concentration
Time frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm
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 22 May 2014.
- Derived from this study: PubMed 26864371Lamport DJ, Lawton CL, Merat N, Jamson H, Myrissa K, Hofman D, Chadwick HK, Quadt F, Wightman JD, Dye L. Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children. Am J Clin Nutr. 2016 Mar;103(3):775-83. doi: 10.3945/ajcn.115.114553. Epub 2016 Feb 10.
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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.
Louise Dye, PhD (Professor) principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape juice polyphenols in people with Cognition, run by University of Leeds at 1 site in United Kingdom.
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 7 inclusion and 11 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 22 May 2014. 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in Cognitive function & Driving Performance (time frame: Measured at baseline, baseline+6 weeks, and baseline+12 weeks of each experimental arm). 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 NCT01411631, 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 22 May 2014.