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Effects of Dietary Interventions on the Aging Brain

U

University Hospital Muenster

Status and phase

Unknown
Phase 3

Conditions

Healthy

Treatments

Dietary Supplement: Omega-3 (fish oil capsules)
Behavioral: Caloric restriction
Dietary Supplement: Placebo
Dietary Supplement: Resveratrol

Study type

Interventional

Funder types

Other

Identifiers

NCT00996229
Ernaehrung-Neuromod 02

Details and patient eligibility

About

The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.

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, 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.

Enrollment

300 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 4 patient groups, including a placebo group

Caloric restriction + placebo supplementation
Experimental group
Treatment:
Dietary Supplement: Placebo
Behavioral: Caloric restriction
Omega-3 supplementation
Experimental group
Treatment:
Dietary Supplement: Omega-3 (fish oil capsules)
Placebo supplementation
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo
Resveratrol supplementation
Experimental group
Treatment:
Dietary Supplement: Resveratrol

Trial contacts and locations

1

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Central trial contact

Agnes Flöel, Professor; Veronica Witte, Dr

Data sourced from clinicaltrials.gov

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