Dairy Intake and Brain Health in Aging

NCT02245035 | Completed DMC

• 1 other identifier: 12884
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aged Healthy Volunteer

Keywords

Glutathione; Dairy consumption; Brain; Humans

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Dairy Council: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

• In-Young Choi, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 19, 2014
• Study Start: October 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

US (1)