Cognitive AgingNCT00599508
Nutritional Supplementation in Cognitive Aging
A study testing Concord grape juice, blueberry juice and whole fruit blueberry powder in people with Cognitive Aging, run by University of Cincinnati at 1 site in United States.
Trial summary
To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Cognitive Aging
- What is being tested?
- Concord grape juice, blueberry juice and whole fruit blueberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2015
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mild Cognitive Impairment
Who cannot join
- Diabetes
- Weight of under 100 or over 210 pounds
- Chronic use of pain medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45267-0559
About this study
To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults
Read the detailed description
Randomized trials involving daily supplementation with berry fruits in older adults with early memory changes. The berry products include Concord grape juice, blueberry juice, and whole fruit blueberry powder. Supplementation periods are 12 and 16 weeks, depending on berry product. The Aims of the studies are to assess effects on cognitive performance and in a subset of participants, in brain activity.
- Conditions
- Cognitive Aging
- Being tested
- Concord grape juice, placebo juice, blueberry juice, whole fruit blueberry powder, berry placebo powder
- Keywords
- memory, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concord grape juiceDietary supplement
Also called Welch's Concord Grape Juice
Several ounces Concord grape juice administered 3 times a day for 12 or 16 weeks. Specific dosage determined by participant's weight.
placebo juiceDietary supplement
several ounces placebo juice consumed three times a day for 12 or 16 weeks; dosage determined according to participant's weight
blueberry juiceDietary supplement
wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight
whole fruit blueberry powderDietary supplement
whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks
berry placebo powderDietary supplement
berry placebo powder administered daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| grape juice active intervention | Active comparator | Concord grape juice administered daily for 12 or 16 weeks Receives: Dietary Supplement: Concord grape juice |
| juice placebo | Placebo comparator | berry placebo juice administered daily for 12 or 16 weeks Receives: Dietary Supplement: placebo juice |
| blueberry juice active intervention | Active comparator | wild blueberry juice administered daily for 12 weeks Receives: Dietary Supplement: blueberry juice |
| blueberry powder intervention | Active comparator | whole fruit blueberry powder administered daily for 16 weeks Receives: Dietary Supplement: whole fruit blueberry powder |
| powder placebo | Placebo comparator | placebo powder administered daily for 16 weeks Receives: Dietary Supplement: berry placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
memory performance
Measured: at the end of the intervention
Secondary outcomes (1)
cortisol
Measured: at the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive AgingStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Welch Foods Incorporated, U.S. Highbush Blueberry Council
- Responsible party
- Principal investigator, Robert Krikorian, University of Cincinnati
- Investigators
- Robert Krikorian, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599508
- Sponsor's protocol ID
- 06-03-20-08
- Status last verified
- Oct 2016
- First submitted
- 10 Jan 2008
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplementation in Cognitive Aging
- ClinicalTrials.gov ID
- NCT00599508
- Acronym / sponsor ID
- 06-03-20-08
- Conditions
- Cognitive Aging
- Keywords
- memory, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Welch Foods Incorporated, U.S. Highbush Blueberry Council
- Study start
- Jun 2006
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Jan 2008 (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.
To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults
Detailed description
Randomized trials involving daily supplementation with berry fruits in older adults with early memory changes. The berry products include Concord grape juice, blueberry juice, and whole fruit blueberry powder. Supplementation periods are 12 and 16 weeks, depending on berry product. The Aims of the studies are to assess effects on cognitive performance and in a subset of participants, in brain activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| grape juice active intervention | Active comparator | Dietary Supplement: Concord grape juiceConcord grape juice administered daily for 12 or 16 weeks |
| juice placebo | Placebo comparator | Dietary Supplement: placebo juiceberry placebo juice administered daily for 12 or 16 weeks |
| blueberry juice active intervention | Active comparator | Dietary Supplement: blueberry juicewild blueberry juice administered daily for 12 weeks |
| blueberry powder intervention | Active comparator | Dietary Supplement: whole fruit blueberry powderwhole fruit blueberry powder administered daily for 16 weeks |
| powder placebo | Placebo comparator | Dietary Supplement: berry placebo powderplacebo powder administered daily for 16 weeks |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Mild Cognitive Impairment
Key exclusion criteria (3 listed)
- Diabetes
- Weight of under 100 or over 210 pounds
- Chronic use of pain medication
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 |
|---|---|---|
| Concord grape juiceAlso: Welch's Concord Grape JuiceSeveral ounces Concord grape juice administered 3 times a day for 12 or 16 weeks. Specific dosage determined by participant's weight. | Dietary supplement | grape juice active intervention |
| placebo juiceseveral ounces placebo juice consumed three times a day for 12 or 16 weeks; dosage determined according to participant's weight | Dietary supplement | juice placebo |
| blueberry juicewild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight | Dietary supplement | blueberry juice active intervention |
| whole fruit blueberry powderwhole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks | Dietary supplement | blueberry powder intervention |
| berry placebo powderberry placebo powder administered daily for 16 weeks | Dietary supplement | powder placebo |
Primary outcome
memory performance
Time frame: at the end of the intervention
1 secondary outcome
cortisol
Time frame: at the end of the intervention
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 10 Oct 2016.
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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.
Robert Krikorian, Ph.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concord grape juice, blueberry juice and whole fruit blueberry powder in people with Cognitive Aging, run by University of Cincinnati at 1 site in United States.
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 1 inclusion and 3 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 10 Oct 2016. 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 States. 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?
memory performance (time frame: at the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2016.