Milk Intervention Study for Brain Aging

NCT02957422 | Completed

• 1 other identifier: STUDY00140131
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Aging

Keywords

milk; brain aging; antioxidant; glutathione; dietary intervention; brain imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dietary intervention

EXPERIMENTAL

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

Dietary Supplement: 1% Milk

Control

ACTIVE COMPARATOR

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

Dietary Supplement: Control

Interventions

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.

Dietary intervention

Control DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Dairy Management Inc.: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• 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.

  PMID: 36046132 DERIVED

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• In-Young Choi, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 7, 2016
• Study Start: April 7, 2017
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)