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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01219244

Enrollment

330

Registered

2010-10-13

Start date

2010-08-31

Completion date

2016-12-31

Last updated

2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

memory, diet, elderly, cognition, prevention, lifestyle

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.

Interventions

BEHAVIORALcaloric restriction

6 months of caloric restriction (15 %)

BEHAVIORALomega-3 supplementation

6 months of omega-3 supplementation

BEHAVIORALresveratrol supplementation

6 months of resveratrol supplementation

BEHAVIORALPlacebo

6 months of placebo intake

BEHAVIORAL2nd step: intervention + physical / cognitive training

most effective dietary intervention plus physical and cognitive training

BEHAVIORAL2nd step: intervention + control

most effective dietary intervention plus control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026