Milk Intervention Study for Brain Aging

Brain Aging Clinical Trial

Official title:

Dairy Intake and Cerebral Antioxidant Defense in Aging: a Dietary Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957422
• Other study ID #: STUDY00140131
• Status: Completed
• Phase: N/A
• Start date: April 7, 2017
• Est. completion date: September 11, 2019

Study information

• Verified date: May 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Aging

Intervention

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.
• Control
Participants will continue on their regular low dairy diet of =1.5 dairy serving/day.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Dairy Management Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glutathione (GSH) levels	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.	Change from Baseline to Month 3