Effects of Dietary Interventions on the Aging Brain

This study is currently recruiting participants.

Verified April 2013 by University Hospital Muenster

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2009

Last Updated Date

April 18, 2013

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Auditory verbal Learning Task [ Time Frame: Baseline (timepoint 0), after 6 months (timepoint 6 months) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Auditory verbal Learning Task [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00996229 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Functional/Structural brain changes [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]
Plasma biomarkers [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Dietary Interventions on the Aging Brain

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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 Arm (s)

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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

February 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Veronica Witte, Dr		veronica.witte@charite.de
Contact: Agnes Flöel, Professor		agnes.floeel@charite.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00996229

Other Study ID Numbers ^ICMJE

Ernaehrung-Neuromod 02

Has Data Monitoring Committee

Yes

Responsible Party

Agnes Floel, University Hospital Muenster

Study Sponsor ^ICMJE

University Hospital Muenster

Collaborators ^ICMJE

Charite University, Berlin, Germany

Investigators ^ICMJE

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

Information Provided By

University Hospital Muenster

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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