Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)

Phase 2

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Placebo; Behavioral: resveratrol supplementation; Behavioral: caloric restriction; Behavioral: omega-3 supplementation

• Registration Number: NCT01219244
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.

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, dietary modification (caloric restriction, omega-3 fatty acids and resveratrol) should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with mild cognitive impairment.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• subjects with mild cognitive impairment
• 50-80 years old
• moderate to heavy weight (BMI 25-35)

Exclusion Criteria

• dementia
• diabetes
• severe disease
• younger than 50 years
• BMI < 25

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
resveratrol supplementation	resveratrol supplementation	-
Caloric restriction	caloric restriction	-
omega-3 supplementation	omega-3 supplementation	-

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale - cognitive subscale	Prior to intervention and after 6 months of intervention

Secondary Outcome Measures

Name	Time	Method
Functional/Structural brain changes	Prior to intervention and after 6 months of intervention
Plasma biomarkers	Prior to intervention and after 6 months of intervention

Trial Locations

Locations (1)

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