Milk Intervention Study for Brain Aging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2019-09-11

Brief Summary

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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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Detailed Description

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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.

Conditions

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Brain Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dietary intervention

Participants will receive dietary intervention. Participants will be taking 3 servings of dairy/day.

Group Type EXPERIMENTAL

1% Milk

Intervention Type 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

Participants will receive no additional intervention. Participants will continue on their regular diet, which includes ≤1.5 dairy serving/day.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Control

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes