Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Dietary Interventions on the Aging Brain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital Muenster
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Agnes Floel, University Hospital Muenster Identifier:
First received: October 14, 2009
Last updated: April 18, 2013
Last verified: April 2013

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
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.


Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00996229

Contact: Veronica Witte, Dr
Contact: Agnes Flöel, Professor

Department of Neurology, Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Veronica Witte, Dr   
Contact: Agnes Flöel, Professor   
Sponsors and Collaborators
University Hospital Muenster
Charite University, Berlin, Germany
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 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:
cognitive decline

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Sensory System Agents
Therapeutic Uses processed this record on February 25, 2015