Effects of Dietary Interventions on the Aging Brain

• ClinicalTrials.gov Identifier: NCT00996229
• Recruitment Status: Unknown
• First Posted: October 16, 2009
• Last Update Posted: April 19, 2013
• Sponsor: University Hospital Muenster
• Collaborator: Charite University, Berlin, Germany
• Information provided by (Responsible Party): Agnes Floel, University Hospital Muenster

Tracking Information

• First Submitted Date: October 14, 2009
• First Posted Date: October 16, 2009
• Last Update Posted Date: April 19, 2013
• Study Start Date: November 2009
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 7, 2011): Auditory verbal Learning Task [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ]
• Original Primary Outcome Measures (submitted: October 15, 2009): Auditory verbal Learning Task [ Time Frame: Prior to intervention and after 6 months of intervention ]

Current Secondary Outcome Measures (submitted: November 7, 2011)

• 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 ]

Original Secondary Outcome Measures (submitted: October 15, 2009)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Dietary Interventions on the Aging Brain
• Official Title: Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People
• Brief Summary: 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Prevention
• Condition: Healthy

Intervention

• Behavioral: Caloric restriction
  20-30% CR for 6 months
• Dietary Supplement: Omega-3 (fish oil capsules)
  2g/day DHA/EPA capsules for 6 months
• Dietary Supplement: Placebo
  Daily corn oil capsules for 6 months
• Dietary Supplement: Resveratrol
  daily resveratrol for 6 months

Study Arms

• Experimental: Caloric restriction + placebo supplementation
  Interventions:

  • Behavioral: Caloric restriction
  • Dietary Supplement: Placebo
• Experimental: Omega-3 supplementation
  Intervention: Dietary Supplement: Omega-3 (fish oil capsules)
• Placebo Comparator: Placebo supplementation
  Intervention: Dietary Supplement: Placebo
• Experimental: Resveratrol supplementation
  Intervention: Dietary Supplement: Resveratrol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 15, 2009): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2014
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00996229
• Other Study ID Numbers: Ernaehrung-Neuromod 02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Agnes Floel, University Hospital Muenster
• Study Sponsor: University Hospital Muenster
• Collaborators: Charite University, Berlin, Germany

Investigators

• Study Chair: Agnes Flöel, Professor; Charite University, Berlin, Germany
• Principal Investigator: Veronica Witte, Dr; Charite University, Berlin, Germany

• PRS Account: University Hospital Muenster
• Verification Date: April 2013