Milk Intervention Study for Brain Aging

Not Applicable

Completed

• Conditions: Brain Aging
• Interventions: Dietary Supplement: Control; Dietary Supplement: 1% Milk

• Registration Number: NCT02957422
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-06
• Study Start: 2017-04-07
• Primary Completion: 2019-09-11
• Study Completion: 2019-09-11
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Participants will receive no additional intervention. Participants will continue on their regular diet, which includes ≤1.5 dairy serving/day.
Dietary intervention	1% Milk	Participants will receive dietary intervention. Participants will be taking 3 servings of dairy/day.

Primary Outcome Measures

Name	Time	Method
Change in Glutathione (GSH) levels	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States