Milk Intervention Study for Brain Aging

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Aging
• Intervention / Treatment: Dietary supplement: 1% Milk; Dietary supplement: Control

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2017
• Primary Completion (Actual): September 11, 2019
• Study Completion (Actual): September 11, 2019

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: milk; antioxidant; dietary intervention; glutathione; brain imaging; brain aging
• Other Study ID Numbers: STUDY00140131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No