Effects of Dietary Interventions on the Aging Brain

Healthy Clinical Trial

Official title:

Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00996229
• Other study ID #: Ernaehrung-Neuromod 02
• Status: Recruiting
• Phase: Phase 3
• First received: October 14, 2009
• Last updated: April 18, 2013
• Start date: November 2009
• Est. completion date: February 2014

Study information

• Verified date: April 2013
• Source: University Hospital Muenster
• Contact: Veronica Witte, Dr
• Email: veronica.witte[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• 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
• Placebo
Daily corn oil capsules for 6 months
• Resveratrol
daily resveratrol for 6 months

Locations

Country	Name	City	State
Germany	Department of Neurology, Charité Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory verbal Learning Task		Baseline (timepoint 0), after 6 months (timepoint 6 months)	No
Secondary	Functional/Structural brain changes		Baseline (timepoint 0), after 6 months (timepoint 6 months)	No
Secondary	Plasma biomarkers		Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention	No