HealthyPhase 3NCT00996229
Effects of Dietary Interventions on the Aging Brain
A Phase 3 study testing Caloric restriction, Omega-3 (fish oil capsules) and Resveratrol in people with Healthy, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The researchers will investigate whether caloric restriction or dietary supplementation 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?
- Caloric restriction, Omega-3 (fish oil capsules) and Resveratrol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Feb 2014
- 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 (BMI 25-30)
- must be able to change diet/take supplements at home
Who cannot join
- diabetes
- younger than 50 years
- BMI < 25
- psychiatric medication
- severe disease
- MMSE < 26
- eating disorders
Trial locations and contacts
1 site in 1 country.
Veronica Witte, Dr contact
Agnes Flöel, Professor contact
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Veronica Witte, Dr, veronica.witte@charite.de
Agnes Flöel, Professor, agnes.floeel@charite.de
About this study
Official title: Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People
The researchers will investigate whether caloric restriction or dietary supplementation 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 devastating effects.
Referring to animal data, empirical studies, and pilot human trials, 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, the researchers study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.
- Conditions
- Healthy
- Being tested
- Caloric restriction, Omega-3 (fish oil capsules), Placebo, Resveratrol
- Keywords
- Diet, elderly, cognition, prevention, cognitive decline, Lifestyle
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restrictionBehavioural
20-30% CR for 6 months
Omega-3 (fish oil capsules)Dietary supplement
2g/day DHA/EPA capsules for 6 months
PlaceboDietary supplement
Daily corn oil capsules for 6 months
ResveratrolDietary supplement
daily resveratrol for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Caloric restriction + placebo supplementation | Experimental | Not described Receives: Behavioral: Caloric restriction; Dietary Supplement: Placebo |
| Omega-3 supplementation | Experimental | Not described Receives: Dietary Supplement: Omega-3 (fish oil capsules) |
| Placebo supplementation | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Resveratrol supplementation | Experimental | Not described Receives: Dietary Supplement: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory verbal Learning Task
Measured: Baseline (timepoint 0), after 6 months (timepoint 6 months)
Secondary outcomes (2)
Functional/Structural brain changes
Measured: Baseline (timepoint 0), after 6 months (timepoint 6 months)
Plasma biomarkers
Measured: Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (estimated)
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Agnes Floel, University Hospital Muenster
- Investigators
- Agnes Flöel, Professor, Study chair, Charite University, Berlin, GermanyVeronica Witte, Dr, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996229
- Sponsor's protocol ID
- Ernaehrung-Neuromod 02
- Status last verified
- Apr 2013
- First submitted
- 14 Oct 2009
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People
- ClinicalTrials.gov ID
- NCT00996229
- Acronym / sponsor ID
- Ernaehrung-Neuromod 02
- Conditions
- Healthy
- Keywords
- Diet, elderly, cognition, prevention, cognitive decline, Lifestyle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 16 Oct 2009 (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.
The researchers will investigate whether caloric restriction or dietary supplementation 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 devastating effects.
Referring to animal data, empirical studies, and pilot human trials, 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, the researchers 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
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caloric restriction + placebo supplementation | Experimental | Behavioral: Caloric restriction, Dietary Supplement: Placebo |
| Omega-3 supplementation | Experimental | Dietary Supplement: Omega-3 (fish oil capsules) |
| Placebo supplementation | Placebo comparator | Dietary Supplement: Placebo |
| Resveratrol supplementation | Experimental | Dietary Supplement: Resveratrol |
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 (BMI 25-30)
- must be able to change diet/take supplements at home
Key exclusion criteria (7 listed)
- diabetes
- younger than 50 years
- BMI < 25
- psychiatric medication
- severe 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 |
|---|---|---|
| Caloric restriction20-30% CR for 6 months | Behavioural | Caloric restriction + placebo supplementation |
| Omega-3 (fish oil capsules)2g/day DHA/EPA capsules for 6 months | Dietary supplement | Omega-3 supplementation |
| PlaceboDaily corn oil capsules for 6 months | Dietary supplement | Caloric restriction + placebo supplementation, Placebo supplementation |
| Resveratroldaily resveratrol for 6 months | Dietary supplement | Resveratrol supplementation |
Primary outcome
Auditory verbal Learning Task
Time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)
2 secondary outcomes
Functional/Structural brain changes
Time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)
Plasma biomarkers
Time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
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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.
Veronica Witte, Dr contact
Agnes Flöel, Professor contact
Agnes Flöel, Professor study chair
Charite University, Berlin, Germany
Veronica Witte, Dr principal investigator
Charite University, Berlin, Germany
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 Caloric restriction, Omega-3 (fish oil capsules) and Resveratrol 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 7 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: status not confirmed, as of the sponsor's last update on 19 Apr 2013. 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. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronica Witte, Dr (veronica.witte@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory verbal Learning Task (time frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)). 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 19 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.