Mild Cognitive ImpairmentPhase 2/3NCT01219244
Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)
A Phase 2/3 study testing caloric restriction, omega-3 supplementation and resveratrol supplementation in people with Mild Cognitive Impairment, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- caloric restriction, omega-3 supplementation and resveratrol supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Dec 2016
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with mild cognitive impairment
- 50-80 years old
- moderate to heavy weight (BMI 25-35)
Who cannot join
- dementia
- diabetes
- severe disease
- younger than 50 years
- BMI < 25
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Charité Universitätsmedizin Berlin
Berlin
About this study
Official title: Enhancing Memory Functions in Patients With Mild Cognitive Impairment by Dietary Interventions and in Combination With Exercise and Cognitive Training - Proof of Concept and Mechanisms
The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.
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, dietary modification (caloric restriction, omega-3 fatty acids and resveratrol) should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- caloric restriction, omega-3 supplementation, resveratrol supplementation, Placebo, 2nd step: intervention + physical / cognitive training
- Keywords
- memory, diet, elderly, cognition, prevention, 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
6 months of caloric restriction (15 %)
omega-3 supplementationBehavioural
6 months of omega-3 supplementation
resveratrol supplementationBehavioural
6 months of resveratrol supplementation
PlaceboBehavioural
6 months of placebo intake
2nd step: intervention + physical / cognitive trainingBehavioural
most effective dietary intervention plus physical and cognitive training
2nd step: intervention + controlBehavioural
most effective dietary intervention plus control
| Study group | Role | What they receive |
|---|---|---|
| Caloric restriction | Experimental | Not described Receives: Behavioral: caloric restriction |
| omega-3 supplementation | Experimental | Not described Receives: Behavioral: omega-3 supplementation |
| resveratrol supplementation | Experimental | Not described Receives: Behavioral: resveratrol supplementation |
| placebo | Placebo comparator | Not described Receives: Behavioral: Placebo |
| 2nd step: intervention + physical /cognitive training | Experimental | most effective dietary intervention plus physical and cognitive training Receives: Behavioral: 2nd step: intervention + physical / cognitive training |
| 2nd step: most effective dietary intervention plus control | Placebo comparator | most effective dietary intervention plus control Receives: Behavioral: 2nd step: intervention + control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale - cognitive subscale
Measured: Prior to intervention and after 6 months of intervention
Secondary outcomes (2)
Functional/Structural brain changes
Measured: Prior to intervention and after 6 months of intervention
Plasma biomarkers
Measured: Prior to intervention and after 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Floeel, Prof., Study chair, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219244
- Sponsor's protocol ID
- nutrition_memory_01
- Status last verified
- Jul 2017
- First submitted
- 12 Oct 2010
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kobe T, Witte AV, Schnelle A, Lesemann A, Fabian S, Tesky VA, Pantel J, Floel A. Combined omega-3 fatty acids, aerobic exercise and cognitive stimulation prevents decline in gray matter volume of the frontal, parietal and cingulate cortex in patients with mild cognitive impairment. Neuroimage. 2016 May 1;131:226-38. doi: 10.1016/j.neuroimage.2015.09.050. Epub 2015 Oct 1.
PubMed 26433119Kobe T, Witte AV, Schnelle A, Tesky VA, Pantel J, Schuchardt JP, Hahn A, Bohlken J, Grittner U, Floel A. Impact of Resveratrol on Glucose Control, Hippocampal Structure and Connectivity, and Memory Performance in Patients with Mild Cognitive Impairment. Front Neurosci. 2017 Mar 7;11:105. doi: 10.3389/fnins.2017.00105. eCollection 2017.
PubMed 28326010Witte AV, Kobe T, Graunke A, Schuchardt JP, Hahn A, Tesky VA, Pantel J, Floel A. Impact of leptin on memory function and hippocampal structure in mild cognitive impairment. Hum Brain Mapp. 2016 Dec;37(12):4539-4549. doi: 10.1002/hbm.23327. Epub 2016 Aug 11.
PubMed 27511061Wirth M, Pichet Binette A, Brunecker P, Kobe T, Witte AV, Floel A. Divergent regional patterns of cerebral hypoperfusion and gray matter atrophy in mild cognitive impairment patients. J Cereb Blood Flow Metab. 2017 Mar;37(3):814-824. doi: 10.1177/0271678X16641128. Epub 2016 Jul 20.
PubMed 27037094Kobe T, Witte AV, Schnelle A, Grittner U, Tesky VA, Pantel J, Schuchardt JP, Hahn A, Bohlken J, Rujescu D, Floel A. Vitamin B-12 concentration, memory performance, and hippocampal structure in patients with mild cognitive impairment. Am J Clin Nutr. 2016 Apr;103(4):1045-54. doi: 10.3945/ajcn.115.116970. Epub 2016 Feb 24.
PubMed 26912492
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Memory Functions in Patients With Mild Cognitive Impairment by Dietary Interventions and in Combination With Exercise and Cognitive Training - Proof of Concept and Mechanisms
- ClinicalTrials.gov ID
- NCT01219244
- Acronym / sponsor ID
- nutrition_memory_01
- Conditions
- Mild Cognitive Impairment
- Keywords
- memory, diet, elderly, cognition, prevention, lifestyle
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Aug 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Oct 2010 (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 study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.
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, dietary modification (caloric restriction, omega-3 fatty acids and resveratrol) should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with mild cognitive impairment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Caloric restriction | Experimental | Behavioral: caloric restriction |
| omega-3 supplementation | Experimental | Behavioral: omega-3 supplementation |
| resveratrol supplementation | Experimental | Behavioral: resveratrol supplementation |
| placebo | Placebo comparator | Behavioral: Placebo |
| 2nd step: intervention + physical /cognitive training | Experimental | Behavioral: 2nd step: intervention + physical / cognitive trainingmost effective dietary intervention plus physical and cognitive training |
| 2nd step: most effective dietary intervention plus control | Placebo comparator | Behavioral: 2nd step: intervention + controlmost effective dietary intervention plus control |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects with mild cognitive impairment
- 50-80 years old
- moderate to heavy weight (BMI 25-35)
Key exclusion criteria (5 listed)
- dementia
- diabetes
- severe disease
- younger than 50 years
- BMI < 25
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 restriction6 months of caloric restriction (15 %) | Behavioural | Caloric restriction |
| omega-3 supplementation6 months of omega-3 supplementation | Behavioural | omega-3 supplementation |
| resveratrol supplementation6 months of resveratrol supplementation | Behavioural | resveratrol supplementation |
| Placebo6 months of placebo intake | Behavioural | placebo |
| 2nd step: intervention + physical / cognitive trainingmost effective dietary intervention plus physical and cognitive training | Behavioural | 2nd step: intervention + physical /cognitive training |
| 2nd step: intervention + controlmost effective dietary intervention plus control | Behavioural | 2nd step: most effective dietary intervention plus control |
Primary outcome
Alzheimer's Disease Assessment Scale - cognitive subscale
Time frame: Prior to intervention and after 6 months of intervention
2 secondary outcomes
Functional/Structural brain changes
Time frame: Prior to intervention and after 6 months of intervention
Plasma biomarkers
Time frame: Prior to intervention and after 6 months of 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 28 Jul 2017.
- Results publication: PubMed 26433119Kobe T, Witte AV, Schnelle A, Lesemann A, Fabian S, Tesky VA, Pantel J, Floel A. Combined omega-3 fatty acids, aerobic exercise and cognitive stimulation prevents decline in gray matter volume of the frontal, parietal and cingulate cortex in patients with mild cognitive impairment. Neuroimage. 2016 May 1;131:226-38. doi: 10.1016/j.neuroimage.2015.09.050. Epub 2015 Oct 1.
- Results publication: PubMed 28326010Kobe T, Witte AV, Schnelle A, Tesky VA, Pantel J, Schuchardt JP, Hahn A, Bohlken J, Grittner U, Floel A. Impact of Resveratrol on Glucose Control, Hippocampal Structure and Connectivity, and Memory Performance in Patients with Mild Cognitive Impairment. Front Neurosci. 2017 Mar 7;11:105. doi: 10.3389/fnins.2017.00105. eCollection 2017.
- Results publication: PubMed 27511061Witte AV, Kobe T, Graunke A, Schuchardt JP, Hahn A, Tesky VA, Pantel J, Floel A. Impact of leptin on memory function and hippocampal structure in mild cognitive impairment. Hum Brain Mapp. 2016 Dec;37(12):4539-4549. doi: 10.1002/hbm.23327. Epub 2016 Aug 11.
- Results publication: PubMed 27037094Wirth M, Pichet Binette A, Brunecker P, Kobe T, Witte AV, Floel A. Divergent regional patterns of cerebral hypoperfusion and gray matter atrophy in mild cognitive impairment patients. J Cereb Blood Flow Metab. 2017 Mar;37(3):814-824. doi: 10.1177/0271678X16641128. Epub 2016 Jul 20.
- Results publication: PubMed 26912492Kobe T, Witte AV, Schnelle A, Grittner U, Tesky VA, Pantel J, Schuchardt JP, Hahn A, Bohlken J, Rujescu D, Floel A. Vitamin B-12 concentration, memory performance, and hippocampal structure in patients with mild cognitive impairment. Am J Clin Nutr. 2016 Apr;103(4):1045-54. doi: 10.3945/ajcn.115.116970. Epub 2016 Feb 24.
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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.
Agnes Floeel, Prof. study chair
Charité University Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing caloric restriction, omega-3 supplementation and resveratrol supplementation in people with Mild Cognitive Impairment, run by Charite University, Berlin, Germany 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 3 inclusion and 5 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 28 Jul 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Alzheimer's Disease Assessment Scale - cognitive subscale (time frame: Prior to intervention and after 6 months of intervention). 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 NCT01219244, which also lists 5 linked publications.
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 28 Jul 2017.