Dairy Intake and Brain Health in Aging

NCT ID: NCT02245035

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-12-31

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Low dairy intake

1 serving/day or less of dairy food characterized at enrollment using 24 hr dietary recall

No interventions assigned to this group

Moderate Dairy Intake

1-2 servings/day of dairy food characterized at enrollment using 24 hr dietary recall

No interventions assigned to this group

Recommended Dairy Intake

Greater than 3 servings/day of dairy food characterized at enrollment using 24 hr dietary recall

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Dairy Council

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

In-Young Choi, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Young Choi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

12884

Identifier Type: -

Identifier Source: org_study_id