Brain AgingNCT02957422
Milk Intervention Study for Brain Aging
A study testing 1% Milk in people with Brain Aging, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Aging
- What is being tested?
- 1% Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 11 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Aging
- Being tested
- 1% Milk, Control
- Keywords
- milk, brain aging, antioxidant, glutathione, dietary intervention, brain imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% MilkDietary 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.
ControlDietary supplement
Participants will continue on their regular low dairy diet of ≤1.5 dairy serving/day.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Participants will receive dietary intervention. Participants will be taking 3 servings of dairy/day. Receives: 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. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start7 Apr 2017
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Sponsor
- Investigators
- In-Young Choi, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957422
- Sponsor's protocol ID
- STUDY00140131
- Status last verified
- May 2021
- First submitted
- 4 Nov 2016
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36046132
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Intake and Cerebral Antioxidant Defense in Aging: a Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT02957422
- Acronym / sponsor ID
- STUDY00140131
- Conditions
- Brain Aging
- Keywords
- milk, brain aging, antioxidant, glutathione, dietary intervention, brain imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Dietary Supplement: 1% MilkParticipants will receive dietary intervention. Participants will be taking 3 servings of dairy/day. |
| Control | Active comparator | Dietary Supplement: ControlParticipants will receive no additional intervention. Participants will continue on their regular diet, which includes ≤1.5 dairy serving/day. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% Milk1.5 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 supplement | Dietary intervention |
| ControlParticipants will continue on their regular low dairy diet of ≤1.5 dairy serving/day. | Dietary supplement | Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 36046132Choi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Young Choi, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1% Milk in people with Brain Aging, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glutathione (GSH) levels (time frame: Change from Baseline to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.