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Dairy Intake and Brain Health in Aging

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ClinicalTrials.gov Identifier: NCT02245035
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
National Dairy Council
Information provided by (Responsible Party):
In-Young Choi, Ph.D., University of Kansas Medical Center

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.

Condition or disease
Aged Healthy Volunteer

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dairy Intake and Brain Health in Aging
Study Start Date : October 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2014

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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy elderly individuals with an age range of 60-85 years.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245035


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Dairy Council
Investigators
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Principal Investigator: In-Young Choi, PhD University of Kansas Medical Center

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Responsible Party: In-Young Choi, Ph.D., Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02245035     History of Changes
Other Study ID Numbers: 12884
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by In-Young Choi, Ph.D., University of Kansas Medical Center:
Glutathione
Dairy consumption
Brain
Humans