NCT00463255

Brief Summary

We investigate whether a change in diet could provide positive effects on general brain functions in healthy elderly people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

First QC Date

April 18, 2007

Last Update Submit

November 7, 2011

Conditions

Healthy

Keywords

Dietelderlyage-related diseasespreventioncognitive declineClinical study

Outcome Measures

Primary Outcomes (1)

  • implicit visual-motor learning of a finger sequence of the hand.

Secondary Outcomes (2)

  • implicit learning of an artificial language

  • several plasma levels related to cognitive functions

Interventions

dietBEHAVIORAL

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
  • must be able to change diet at home

You may not qualify if:

  • diabetes
  • younger than 50 years
  • BMI \< 23
  • already participating in other studys
  • MMSE \> 26
  • eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Muenster, Department of Neurology

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Diet

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Stefan Knecht, MD, Prof.

    University Hospital Muenster

    STUDY CHAIR

  • Bernd E Ringelstein, MD, Prof

    University Hopsital Muenster

    STUDY CHAIR

  • Agnes Floeel, MD

    University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

August 1, 2006

Study Completion

October 1, 2008

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

DE(1)