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Completed

NCT Number: NCT02957422

Milk Intervention Study for Brain Aging

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.

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Key information

Conditions

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% milk

Dietary Supplement

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

Dietary Supplement

Participants will continue on their regular low dairy diet of ≤1.5 dairy serving/day.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Dairy Management Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2016
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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