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
|Condition or disease||Intervention/treatment||Phase|
|Brain Aging||Dietary Supplement: 1% Milk Dietary Supplement: Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||In-Young Choi, PhD||University of Kansas Medical Center|