Effects of Dietary Interventions on the Aging Brain

Phase 3

• Conditions: Healthy
• Interventions: Behavioral: Caloric restriction; Dietary Supplement: Omega-3 (fish oil capsules); Dietary Supplement: Resveratrol; Dietary Supplement: Placebo

• Registration Number: NCT00996229
• Lead Sponsor: University Hospital Muenster

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 Timeline

• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Study Start: 2009-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-19
• Primary Completion: 2013-12
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caloric restriction + placebo supplementation	Caloric restriction	-
Caloric restriction + placebo supplementation	Placebo	-
Omega-3 supplementation	Omega-3 (fish oil capsules)	-
Placebo supplementation	Placebo	-
Resveratrol supplementation	Resveratrol	-

Primary Outcome Measures

Name	Time	Method
Auditory verbal Learning Task	Baseline (timepoint 0), after 6 months (timepoint 6 months)

Secondary Outcome Measures

Name	Time	Method
Functional/Structural brain changes	Baseline (timepoint 0), after 6 months (timepoint 6 months)
Plasma biomarkers	Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention

Trial Locations

Locations (1)

Department of Neurology, Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany