Effects of Dietary Interventions on the Aging Brain
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ClinicalTrials.gov Identifier: NCT00996229 |
Recruitment Status : Unknown
Verified April 2013 by Agnes Floel, University Hospital Muenster.
Recruitment status was: Recruiting
First Posted : October 16, 2009
Last Update Posted : April 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Behavioral: Caloric restriction Dietary Supplement: Omega-3 (fish oil capsules) Dietary Supplement: Placebo Dietary Supplement: Resveratrol | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Prevention |
Official Title: | Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People |
Study Start Date : | November 2009 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Caloric restriction + placebo supplementation |
Behavioral: Caloric restriction
20-30% CR for 6 months Dietary Supplement: Placebo Daily corn oil capsules for 6 months |
Experimental: Omega-3 supplementation |
Dietary Supplement: Omega-3 (fish oil capsules)
2g/day DHA/EPA capsules for 6 months |
Placebo Comparator: Placebo supplementation |
Dietary Supplement: Placebo
Daily corn oil capsules for 6 months |
Experimental: Resveratrol supplementation |
Dietary Supplement: Resveratrol
daily resveratrol for 6 months |
- Auditory verbal Learning Task [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ]
- 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 ]

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy subjects
- 50-80 years old
- moderate to heavy weight (BMI 25-30)
- must be able to change diet/take supplements at home
Exclusion Criteria:
- diabetes
- younger than 50 years
- BMI < 25
- psychiatric medication
- severe disease
- MMSE < 26
- eating disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996229
Contact: Veronica Witte, Dr | veronica.witte@charite.de | ||
Contact: Agnes Flöel, Professor | agnes.floeel@charite.de |
Germany | |
Department of Neurology, Charité Universitätsmedizin Berlin | Recruiting |
Berlin, Germany, 10117 | |
Contact: Veronica Witte, Dr veronica.witte@charite.de | |
Contact: Agnes Flöel, Professor agnes.floeel@charite.de |
Study Chair: | Agnes Flöel, Professor | Charite University, Berlin, Germany | |
Principal Investigator: | Veronica Witte, Dr | Charite University, Berlin, Germany |
Responsible Party: | Agnes Floel, Prof. Dr. med. Agnes Flöel, University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT00996229 |
Other Study ID Numbers: |
Ernaehrung-Neuromod 02 |
First Posted: | October 16, 2009 Key Record Dates |
Last Update Posted: | April 19, 2013 |
Last Verified: | April 2013 |
Diet elderly cognition |
prevention cognitive decline Lifestyle |
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