Effects of Dietary Interventions on the Aging Brain
This study is currently recruiting participants.
Verified April 2013 by University Hospital Muenster
Sponsor:
University Hospital Muenster
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Agnes Floel, University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00996229
First received: October 14, 2009
Last updated: April 18, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Behavioral: Caloric restriction Dietary Supplement: Omega-3 (fish oil capsules) Dietary Supplement: Placebo Dietary Supplement: Resveratrol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People |
Resource links provided by NLM:
Further study details as provided by University Hospital Muenster:
Primary Outcome Measures:
- Auditory verbal Learning Task [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Functional/Structural brain changes [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ] [ Designated as safety issue: No ]
- Plasma biomarkers [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996229
Contacts
| Contact: Veronica Witte, Dr | veronica.witte@charite.de | |
| Contact: Agnes Flöel, Professor | agnes.floeel@charite.de |
Locations
| 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 | |
Sponsors and Collaborators
University Hospital Muenster
Charite University, Berlin, Germany
Investigators
| Study Chair: | Agnes Flöel, Professor | Charite University, Berlin, Germany |
| Principal Investigator: | Veronica Witte, Dr | Charite University, Berlin, Germany |
More Information
No publications provided
| Responsible Party: | Agnes Floel, Prof. Dr. med. Agnes Flöel, University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT00996229 History of Changes |
| Other Study ID Numbers: | Ernaehrung-Neuromod 02 |
| Study First Received: | October 14, 2009 |
| Last Updated: | April 18, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital Muenster:
|
Diet elderly cognition |
prevention cognitive decline Lifestyle |
Additional relevant MeSH terms:
|
Resveratrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Hematologic Agents Antimutagenic Agents Anticarcinogenic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013