Effects of Dietary Interventions on the Aging Brain | NCT00996229

Studies
Effects of Dietary Interventions on the Aging Brain

NCT00996229

Sponsor

University Hospital Muenster

Status

Unknown status

Last Update Posted

Apr 19, 2013Estimated

Enrollment

300Estimated

Phase

Phase 3

Conditions

Healthy

Interventions

Caloric restriction
Omega-3 (fish oil capsules)
Placebo
Resveratrol

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2013Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2013

Last Update Posted Date

Apr 19, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Agnes Floel, Prof. Dr. med. Agnes Flöel, University Hospital MuensterPrincipal Investigator

Lead Sponsor

University Hospital MuensterOTHER

Collaborators

Name	Class
Charite University, Berlin, Germany	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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, 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Caloric restriction + placebo supplementation	Experimental	Behavioral: Caloric restriction Dietary 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

Name	Type	Description	Arm Group Labels	Other Names
Caloric restriction	Behavioral	20-30% CR for 6 months	Caloric restriction + placebo supplementation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Auditory verbal Learning Task		Baseline (timepoint 0), after 6 months (timepoint 6 months)

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Veronica Witte, Dr	Contact			veronica.witte@charite.de
Agnes Flöel, Professor	Contact			agnes.floeel@charite.de

Overall Officials

Name	Affiliation	Role
Agnes Flöel, Professor	Charite University, Berlin, Germany	Study Chair
Veronica Witte, Dr	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Charité Universitätsmedizin Berlin	Recruiting	Berlin	State of Berlin	10117	Germany

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D031204	Caloric Restriction
D004281	Docosahexaenoic Acids
D005395	Fish Oils
D000077185	Resveratrol

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D002149	Energy Intake

Browse Leaves

Not provided

Browse Branches

Not provided