Alzheimer's DiseaseNCT02921672
Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline
A study testing Mediterranean Diet in people with Alzheimer's Disease and Cognitive Impairment, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
By doing this study, researchers hope to learn if older adults with and without cognitive impairment can adhere to a Mediterranean diet. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Cognitive Impairment
- What is being tested?
- Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Cognitively normal older adults over the age of 65 or individuals with a diagnosis of MCI or AD (any age)
- Have a study partner, if diagnosed with MCI or AD
- Body mass index (BMI) range between 20 - 35 kg/m2
- Speak English as a primary language
Who cannot join
- Serious medical risk
- Adherence to specialized diet regimes
- Already consume a Mediterranean diet pattern
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
By doing this study, researchers hope to learn if older adults with and without cognitive impairment can adhere to a Mediterranean diet.
Read the detailed description
Participants will be given instruction on following the study designed Mediterranean diet. Participation in the study will last about 9 weeks. Each person will be asked to follow the study diet for 6 weeks. During the study, participants will be asked to track the food they eat and will be monitored by a registered dietitian.
Potential participants need to be located within the KC metro area.
- Conditions
- Alzheimer's Disease, Cognitive Impairment
- Being tested
- Mediterranean Diet
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietOther
Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively Normal | Active comparator | Persons who are considered to have normal cognitive function. A registered dietician will meet with each person to discuss the Mediterranean Diet. Receives: Other: Mediterranean Diet |
| Mild Cognitive Impairment | Active comparator | Persons diagnosed mild cognitive impairment (MCI). A registered dietician will meet with each person to discuss the Mediterranean Diet. Receives: Other: Mediterranean Diet |
| Mild to Moderate Alzheimer's Disease | Experimental | Persons diagnosed with mild to moderate Alzheimer's disease (AD). A registered dietician will meet with each person to discuss the Mediterranean Diet. Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing the study
Determine feasibility of this patient population's ability to maintain the diet. Outcome will be measured by the number of participants who complete the entire study.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startMar 2016
- Primary completion22 Jun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Deborah K Sullivan, PhD, RD, LD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921672
- Sponsor's protocol ID
- STUDY00003894
- Other IDs
- P30AG035982
- Status last verified
- Feb 2019
- First submitted
- 29 Sep 2016
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline
- ClinicalTrials.gov ID
- NCT02921672
- Acronym / sponsor ID
- STUDY00003894
- Conditions
- Alzheimer's Disease, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2016
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Oct 2016 (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.
By doing this study, researchers hope to learn if older adults with and without cognitive impairment can adhere to a Mediterranean diet.
Detailed description
Participants will be given instruction on following the study designed Mediterranean diet. Participation in the study will last about 9 weeks. Each person will be asked to follow the study diet for 6 weeks. During the study, participants will be asked to track the food they eat and will be monitored by a registered dietitian.
Potential participants need to be located within the KC metro area.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitively Normal | Active comparator | Other: Mediterranean DietPersons who are considered to have normal cognitive function. A registered dietician will meet with each person to discuss the Mediterranean Diet. |
| Mild Cognitive Impairment | Active comparator | Other: Mediterranean DietPersons diagnosed mild cognitive impairment (MCI). A registered dietician will meet with each person to discuss the Mediterranean Diet. |
| Mild to Moderate Alzheimer's Disease | Experimental | Other: Mediterranean DietPersons diagnosed with mild to moderate Alzheimer's disease (AD). A registered dietician will meet with each person to discuss the Mediterranean Diet. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Cognitively normal older adults over the age of 65 or individuals with a diagnosis of MCI or AD (any age)
- Have a study partner, if diagnosed with MCI or AD
- Body mass index (BMI) range between 20 - 35 kg/m2
- Speak English as a primary language
Key exclusion criteria (3 listed)
- Serious medical risk
- Adherence to specialized diet regimes
- Already consume a Mediterranean diet pattern
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 |
|---|---|---|
| Mediterranean DietDiet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats. | Other | Cognitively Normal, Mild Cognitive Impairment, Mild to Moderate Alzheimer's Disease |
Primary outcome
Number of participants completing the study
Time frame: Week 6
Determine feasibility of this patient population's ability to maintain the diet. Outcome will be measured by the number of participants who complete the entire study.
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 6 Feb 2019.
- 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.
Deborah K Sullivan, PhD, RD, LD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet in people with Alzheimer's Disease and Cognitive Impairment, run by University of Kansas Medical Center 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 4 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 6 Feb 2019. 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. 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?
Number of participants completing the study (time frame: Week 6). 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 6 Feb 2019.