Overview

This trial is active, not recruiting.

Condition aged healthy volunteer
Sponsor University of Kansas Medical Center
Collaborator National Dairy Council
Start date October 2011
End date November 2013
Trial size 60 participants
Trial identifier NCT02245035, 12884

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
1 serving/day or less of dairy food characterized at enrollment using 24 hr dietary recall
1-2 servings/day of dairy food characterized at enrollment using 24 hr dietary recall
Greater than 3 servings/day of dairy food characterized at enrollment using 24 hr dietary recall

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 60 years up to 85 years old.

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

Additional Information

Official title Dairy Intake and Brain Health in Aging
Principal investigator In-Young Choi, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.