Dairy Intake and Brain Health in Aging | NCT02245035

Studies
Dairy Intake and Brain Health in Aging

NCT02245035

Sponsor

University of Kansas Medical Center

Status

Completed

Last Update Posted

Mar 21, 2017Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Aged Healthy Volunteer

Interventions

Not provided

Countries

United States

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Nov 2013Actual

Completion Date

Dec 2014Actual

First Submitted Date

Sep 15, 2014

First Submission Date that Met QC Criteria

Sep 17, 2014

First Posted Date

Sep 19, 2014Estimated

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

Mar 19, 2017

Last Update Posted Date

Mar 21, 2017Actual

Name	Class
National Dairy Council	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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dairy intake		1 serving/day or less of dairy food characterized at enrollment using 24 hr dietary recall
Moderate Dairy Intake		1-2 servings/day of dairy food characterized at enrollment using 24 hr dietary recall
Recommended Dairy Intake		Greater than 3 servings/day of dairy food characterized at enrollment using 24 hr dietary recall

Interventions

Not provided

Measure	Description	Time Frame
Cerebral glutathione (GSH) levels measured by magnetic resonance spectroscopy (MRS)		Baseline
Dietary dairy food intake measured using 7-day diet recording		1 week, prior to MRS scan

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females between 60-85 years of age.
Good general health with no concomitant diseases, which would be expected to interfere with the study
BMI range 20-35 kg/m2

Exclusion Criteria:

Presence of any central neurological disease with the potential to impair cognition(e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, Alzheimer disease, Parkinson's disease) or prior major head trauma with loss of consciousness
Presence of an active unstable and life-threatening systemic illness (e.g., cancer)
Presence of major psychiatric disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (DSM-IV criteria; Geriatric Depression Score>6)
Presence of diabetes mellitus (defined as a clinical diagnosis or use of an anti-diabetic agent) and metabolic syndrome
Use of psychoactive and investigational medications
Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia. All subjects subjects will receive a structural MRI as part of this study. Individuals with evidence of infection, infarction, neoplasm or other lesions will be excluded. Individuals found to have abnormalities in their structural MRI will be referred to their primary physician for further evaluation and management.
Pregnancy
Special diet regimens such as lactose free or vegan

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy elderly individuals with an age range of 60-85 years.

Sampling Method

Non-Probability Sample