Dairy Intake and Brain Health in Aging

March 19, 2017 updated by: In-Young Choi, Ph.D., University of Kansas Medical Center
The purpose of this study is to learn if dairy food consumption may help brain health in aging by protecting nerve cells from oxidative damage.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Presence of an active unstable and life-threatening systemic illness (e.g., cancer)
  3. 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)
  4. Presence of diabetes mellitus (defined as a clinical diagnosis or use of an anti-diabetic agent) and metabolic syndrome
  5. Use of psychoactive and investigational medications
  6. 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.
  7. Pregnancy
  8. Special diet regimens such as lactose free or vegan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Dairy Council

Investigators

  • Principal Investigator: In-Young Choi, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 19, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12884

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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