Clinical trial NCT02957422: Milk Intervention Study for Brain Aging
Official title: Dairy Intake and Cerebral Antioxidant Defense in Aging: a Dietary Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Aging
Keywords: milk
brain aging
antioxidant
glutathione
dietary intervention
brain imaging
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
First posted: 2016-11-06
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Glutathione (GSH) levels
timeFrame: Change from Baseline to Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: In-Young Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi IY, Taylor MK, Lee P, Alhayek SA, Bechtel M, Hamilton-Reeves J, Spaeth K, Adany P, Sullivan DK. Milk intake enhances cerebral antioxidant (glutathione) concentration in older adults: A randomized controlled intervention study. Front Nutr. 2022 Aug 15;9:811650. doi: 10.3389/fnut.2022.811650. eCollection 2022.