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

Charité University Medicine Berlin

Status and phase: Completed; Phase 3; Phase 2

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: caloric restriction; Behavioral: 2nd step: intervention + control; Behavioral: Placebo; Behavioral: omega-3 supplementation; Behavioral: resveratrol supplementation; Behavioral: 2nd step: intervention + physical / cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT01219244

nutrition_memory_01

Details and patient eligibility

About

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

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 6 patient groups, including a placebo group

Caloric restriction

Experimental group

Treatment:

Behavioral: caloric restriction

omega-3 supplementation

Experimental group

Treatment:

Behavioral: omega-3 supplementation

resveratrol supplementation

Experimental group

Treatment:

Behavioral: resveratrol supplementation

placebo

Placebo Comparator group

Treatment:

Behavioral: Placebo

2nd step: intervention + physical /cognitive training

Experimental group

Description:

most effective dietary intervention plus physical and cognitive training

Treatment:

Behavioral: 2nd step: intervention + physical / cognitive training

2nd step: most effective dietary intervention plus control

Placebo Comparator group

Description:

most effective dietary intervention plus control

Treatment:

Behavioral: 2nd step: intervention + control