NCT00996229

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

4.1 years

First QC Date

October 14, 2009

Last Update Submit

April 18, 2013

Conditions

Healthy

Keywords

Dietelderlycognitionpreventioncognitive declineLifestyle

Outcome Measures

Primary Outcomes (1)

  • Auditory verbal Learning Task

    Baseline (timepoint 0), after 6 months (timepoint 6 months)

Secondary Outcomes (2)

  • Functional/Structural brain changes

    Baseline (timepoint 0), after 6 months (timepoint 6 months)

  • Plasma biomarkers

    Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention

Study Arms (4)

Caloric restriction + placebo supplementation

EXPERIMENTAL
Behavioral: Caloric restrictionDietary Supplement: Placebo

Omega-3 supplementation

EXPERIMENTAL
Dietary Supplement: Omega-3 (fish oil capsules)

Placebo supplementation

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Resveratrol supplementation

EXPERIMENTAL
Dietary Supplement: Resveratrol

Interventions

Caloric restrictionBEHAVIORAL

20-30% CR for 6 months

Caloric restriction + placebo supplementation
Omega-3 (fish oil capsules)DIETARY_SUPPLEMENT

2g/day DHA/EPA capsules for 6 months

Omega-3 supplementation
PlaceboDIETARY_SUPPLEMENT

Daily corn oil capsules for 6 months

Caloric restriction + placebo supplementationPlacebo supplementation
ResveratrolDIETARY_SUPPLEMENT

daily resveratrol for 6 months

Resveratrol supplementation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects
  • years old
  • moderate to heavy weight (BMI 25-30)
  • must be able to change diet/take supplements at home

You may not qualify if:

  • diabetes
  • younger than 50 years
  • BMI \< 25
  • psychiatric medication
  • severe disease
  • MMSE \< 26
  • eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Caloric RestrictionDocosahexaenoic AcidsFish OilsResveratrol

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsOilsStilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Agnes Flöel, Professor

    Charite University, Berlin, Germany

    STUDY CHAIR

  • Veronica Witte, Dr

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Witte, Dr

CONTACT

veronica.witte@charite.de

Agnes Flöel, Professor

CONTACT

agnes.floeel@charite.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Agnes Flöel

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 16, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

April 19, 2013

Record last verified: 2013-04

Locations

DE(1)