Aged Healthy VolunteerNCT02245035
Dairy Intake and Brain Health in Aging
An observational study of Aged Healthy Volunteer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn if dairy food consumption may help brain health in aging by protecting nerve cells from oxidative damage. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged Healthy Volunteer
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2014
- Phase
- Observational
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy elderly individuals with an age range of 60-85 years.
Who may be able to join
- Males and females between 60-85 years of age.
- Good general health with no concomitant diseases, which would be expected to interfere with the study
- BMI range 20-35 kg/m2
Who cannot join
- Presence of any central neurological disease with the potential to impair cognition(e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, Alzheimer disease, Parkinson's disease) 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 disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (DSM-IV criteria; Geriatric Depression Score>6)
- Presence of diabetes mellitus (defined as a clinical diagnosis or use of an anti-diabetic agent) and metabolic syndrome
- Use of psychoactive and investigational medications
- Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia. All subjects subjects will receive a structural MRI as part of this study. Individuals with evidence of infection, infarction, neoplasm or other lesions will be excluded. Individuals found to have abnormalities in their structural MRI will be referred to their primary physician for further evaluation and management.
- 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
The purpose of this study is to learn if dairy food consumption may help brain health in aging by protecting nerve cells from oxidative damage.
- Conditions
- Aged Healthy Volunteer
- Keywords
- Glutathione, Dairy consumption, Brain, Humans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low dairy intake | 1 serving/day or less of dairy food characterized at enrollment using 24 hr dietary recall | |
| Moderate Dairy Intake | 1-2 servings/day of dairy food characterized at enrollment using 24 hr dietary recall | |
| Recommended Dairy Intake | Greater than 3 servings/day of dairy food characterized at enrollment using 24 hr dietary recall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral glutathione (GSH) levels measured by magnetic resonance spectroscopy (MRS)
Measured: Baseline
Dietary dairy food intake measured using 7-day diet recording
Measured: 1 week, prior to MRS scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2011
- Primary completionNov 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aged Healthy VolunteerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Principal investigator, In-Young Choi, Ph.D., University of Kansas Medical Center
- Investigators
- In-Young Choi, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245035
- Sponsor's protocol ID
- 12884
- Status last verified
- Mar 2017
- First submitted
- 15 Sep 2014
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Intake and Brain Health in Aging
- ClinicalTrials.gov ID
- NCT02245035
- Acronym / sponsor ID
- 12884
- Conditions
- Aged Healthy Volunteer
- Keywords
- Glutathione, Dairy consumption, Brain, Humans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- Oct 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Sep 2014 (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 dairy food consumption may help brain health in aging by protecting nerve cells from oxidative damage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dairy intake | – | –1 serving/day or less of dairy food characterized at enrollment using 24 hr dietary recall |
| Moderate Dairy Intake | – | –1-2 servings/day of dairy food characterized at enrollment using 24 hr dietary recall |
| Recommended Dairy Intake | – | –Greater than 3 servings/day of dairy food characterized at enrollment using 24 hr dietary recall |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy elderly individuals with an age range of 60-85 years.
Key inclusion criteria (3 listed)
- Males and females between 60-85 years of age.
- Good general health with no concomitant diseases, which would be expected to interfere with the study
- BMI range 20-35 kg/m2
Key exclusion criteria (8 listed)
- Presence of any central neurological disease with the potential to impair cognition(e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, Alzheimer disease, Parkinson's disease) 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 disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (DSM-IV criteria; Geriatric Depression Score>6)
- Presence of diabetes mellitus (defined as a clinical diagnosis or use of an anti-diabetic agent) and metabolic syndrome
- 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.
Primary outcome
Cerebral glutathione (GSH) levels measured by magnetic resonance spectroscopy (MRS)
Time frame: Baseline
Dietary dairy food intake measured using 7-day diet recording
Time frame: 1 week, prior to MRS scan
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 21 Mar 2017.
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Healthy Volunteers
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?
An observational study of Aged Healthy Volunteer, 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 3 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 21 Mar 2017. 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?
Cerebral glutathione (GSH) levels measured by magnetic resonance spectroscopy (MRS) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2017.