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Milk Intervention Study for Brain Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957422
Recruitment Status : Active, not recruiting
First Posted : November 6, 2016
Last Update Posted : December 19, 2019
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this study is to learn if increased dairy food consumption helps brain health in older adults by protecting nerve cells from damage.

Condition or disease Intervention/treatment Phase
Brain Aging Dietary Supplement: 1% Milk Dietary Supplement: Control Not Applicable

Detailed Description:

Eating more dairy foods may improve brain health as people age by increasing the brain's natural defenses to protect nerve cells against chemical stress. Researchers think there may be a relationship between the brain's natural defense system and the amount of dairy food intake. Strengthening these defenses could provide beneficial protection to the brain against neurodegenerative age-related diseases and cognitive decline.

Glutathione (GSH) is a metabolite in the human brain protective system. It plays a key role in protecting cells against oxidative stress, which is one of the major processes contributing to aging and neurodegeneration. Preliminary findings suggest that there may be a correlation between dairy food intake and GSH levels in the aging brain. Magnetic Resonance Spectroscopy (MRS) measures chemicals in the brain. It is a noninvasive measure of the effects of dairy food intake on the major protective metabolite levels in the living human brain in aging.

This study involves using an MRI with special MRS scans to see if adequate dairy food intake may aid in enhancing cerebral protective capacity to fight against age-related disease and cognitive decline in the brain.

Participants will be asked to make a total of six visits to the research site. Participation will last about 3 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dairy Intake and Cerebral Antioxidant Defense in Aging: a Dietary Intervention Study
Actual Study Start Date : January 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Dietary intervention
Participants will receive dietary intervention. Participants will be taking 3 servings of dairy/day.
Dietary Supplement: 1% Milk
1.5 gallons of 1% milk will be delivered to the participant's home weekly. Participants will be asked to drink 3 cups per day for 3 months.

Active Comparator: Control
Participants will receive no additional intervention. Participants will continue on their regular diet, which includes ≤1.5 dairy serving/day.
Dietary Supplement: Control
Participants will continue on their regular low dairy diet of ≤1.5 dairy serving/day.




Primary Outcome Measures :
  1. Change in Glutathione (GSH) levels [ Time Frame: Change from Baseline to Month 3 ]
    GSH levels are measured in frontal and parietal regions of the brain using our multiple quantum filtered chemical shift imaging (MQ CSI) technique with a 3 T clinical scanner.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health with no concomitant diseases which could interfere with the study
  • Low dairy consumption (≤ 1.5 dairy serving/day)
  • Mini‐Mental State Exam (MMSE) ≥ 24
  • body mass index (BMI) range: 18.5 - 35 kg/m2

Exclusion Criteria:

  • Presence of any central neurological diseases 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 disorders within the past 3 years including depression, anxiety, and alcohol or drug abuse
  • Presence of diabetes mellitus, metabolic syndrome or uncontrolled hypertension
  • Use of psychoactive and investigational medications
  • Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
  • Pregnancy
  • 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): NCT02957422


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
Dairy Management Inc.
Investigators
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Principal Investigator: In-Young Choi, PhD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02957422    
Other Study ID Numbers: STUDY00140131
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Kansas Medical Center:
milk
brain aging
antioxidant
glutathione
dietary intervention
brain imaging
Additional relevant MeSH terms:
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Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs