Skip to main content
OpenTrials
Completed

NCT Number: NCT01219244

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Neurology, Charité Universitätsmedizin Berlin

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caloric restriction

Behavioral

6 months of caloric restriction (15 %)

omega-3 supplementation

Behavioral

6 months of omega-3 supplementation

resveratrol supplementation

Behavioral

6 months of resveratrol supplementation

Placebo

Behavioral

6 months of placebo intake

2nd step: intervention + physical / cognitive training

Behavioral

most effective dietary intervention plus physical and cognitive training

2nd step: intervention + control

Behavioral

most effective dietary intervention plus control

Primary outcomes

  1. Alzheimer's Disease Assessment Scale - cognitive subscale

    Time frame: Prior to intervention and after 6 months of intervention

Secondary outcomes

  1. Functional/Structural brain changes

    Time frame: Prior to intervention and after 6 months of intervention

  2. Plasma biomarkers

    Time frame: Prior to intervention and after 6 months of intervention

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Enhancing Memory Functions in Patients With Mild Cognitive Impairment by Dietary Interventions and in Combination With Exercise and Cognitive Training - Proof of Concept and Mechanisms

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2010
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.