HealthyPhase 3NCT00463255
Diet and the Aging Brain
A Phase 3 study testing diet in people with Healthy, run by University Hospital Muenster at 1 site in Germany.
Trial summary
We investigate whether a change in diet could provide positive effects on general brain functions in healthy elderly people. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2006to Oct 2008
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
- 50-80 years old
- moderate to heavy weight
- must be able to change diet at home
Who cannot join
- diabetes
- younger than 50 years
- BMI < 23
- already participating in other studys
- MMSE > 26
- eating disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Muenster, Department of Neurology
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Phase IV Interventional Study: Effect of Diet on Brain Function in Elderly Healthy People
We investigate whether a change in diet could provide positive effects on general brain functions in healthy elderly people.
Read the detailed description
The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as alzheimer's disease are a growing public-health concern with potentially devastating effects.
Refering to animal data and empirical studies, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, we study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.
- Conditions
- Healthy
- Being tested
- diet
- Keywords
- Diet, elderly, age-related diseases, prevention, cognitive decline, Clinical study
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
implicit visual-motor learning of a finger sequence of the hand.
Secondary outcomes (2)
implicit learning of an artificial language
several plasma levels related to cognitive functions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startAug 2006
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Knecht, MD, Prof., Study chair, University Hospital MuensterBernd E Ringelstein, MD, Prof, Study chair, University Hopsital MuensterAgnes Floeel, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463255
- Sponsor's protocol ID
- Ernaehrung-Neuromod 01
- Status last verified
- Nov 2011
- First submitted
- 18 Apr 2007
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Interventional Study: Effect of Diet on Brain Function in Elderly Healthy People
- ClinicalTrials.gov ID
- NCT00463255
- Acronym / sponsor ID
- Ernaehrung-Neuromod 01
- Conditions
- Healthy
- Keywords
- Diet, elderly, age-related diseases, prevention, cognitive decline, Clinical study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Apr 2007 (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.
We investigate whether a change in diet could provide positive effects on general brain functions in healthy elderly people.
Detailed description
The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as alzheimer's disease are a growing public-health concern with potentially devastating effects.
Refering to animal data and empirical studies, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, we study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy subjects
- 50-80 years old
- moderate to heavy weight
- must be able to change diet at home
Key exclusion criteria (6 listed)
- diabetes
- younger than 50 years
- BMI < 23
- already participating in other studys
- MMSE > 26
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 |
|---|---|---|
| diet | Behavioural | – |
Primary outcome
implicit visual-motor learning of a finger sequence of the hand.
2 secondary outcomes
implicit learning of an artificial language
several plasma levels related to cognitive functions
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 8 Nov 2011.
Related trials for Healthy
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
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.
Stefan Knecht, MD, Prof. study chair
University Hospital Muenster
Bernd E Ringelstein, MD, Prof study chair
University Hopsital Muenster
Agnes Floeel, MD principal investigator
University Hospital Muenster
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 diet in people with Healthy, run by University Hospital Muenster at 1 site in Germany.
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 6 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 8 Nov 2011. 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 Germany. 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?
implicit visual-motor learning of a finger sequence of the hand.. 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 8 Nov 2011.