GliosisWYENCT05626907
Does What You Eat Affect Your Brain
A study testing Diet modification #1, Diet modification #2 and Diet modification #3 in people with Gliosis and Obesity, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to use magnetic resonance imaging (MRI) to evaluate the human hypothalamus for signs of inflammation in response to specific diets. This research may lead to a better understanding of how poor nutritional quality may lead to obesity through effects on regions of the brain known to regulate… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Diet modification #1, Diet modification #2 and Diet modification #3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-40 years
- Overweight: BMI 25-29.9 kg/m2
- Willing to undergo randomly assigned 14-day diet modification
Who cannot join
- History of bariatric surgery or active participation in weight-loss program
- Major medical or neurological disorder (e.g., diabetes, multiple sclerosis)
- Anemia or impaired kidney or liver function
- Known gallbladder disease or gallstones
- Hypertriglyceridemia (>350 mg/dl)
- Current use of orlistat or other weight-loss medications or other medications known to alter appetite (e.g., atypical anti-psychotics)
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- More than moderate level of physical activity (>1000 met-min/wk)
- Pregnancy, menopause, or breastfeeding
- MRI contraindication (e.g., implanted metal, claustrophobia)
- Lifetime eating disorder
- Current smoking or heavy alcohol use (≥ 2 drinks per day for females and ≥ 3 drinks per day for males)
- Weight > 350 pounds (MRI limit)
- Dietary restrictions (e.g., vegan) incompatible with controlled diets
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effect of Diet on Hypothalamic Gliosis in Humans
The purpose of this study is to use magnetic resonance imaging (MRI) to evaluate the human hypothalamus for signs of inflammation in response to specific diets. This research may lead to a better understanding of how poor nutritional quality may lead to obesity through effects on regions of the brain known to regulate body weight.
- Being tested
- Diet modification #1, Diet modification #2, Diet modification #3
- Medical subject headings
- Gliosis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet modification #1Other
Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 130% of estimated daily caloric needs and for the other 7 days, meals will be low in calories, consistent with recommendations for weight loss.
Diet modification #2Other
Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 150% of estimated daily caloric needs and for the other 7 days, meals will be meals will be low in calories, consistent with recommendations for weight loss.
Diet modification #3Other
Participants will be provided all meals for a 14-day period to be approximately 100% of estimated daily caloric needs.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Diet #1 | Experimental | Not described Receives: Other: Diet modification #1 |
| Assigned Diet #2 | Experimental | Not described Receives: Other: Diet modification #2 |
| Assigned Diet #3 | Other | Not described Receives: Other: Diet modification #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic Gliosis
T2 relaxation time as measured by brain MRI
Measured: 7 days of diet intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start13 Jan 2023
- Primary completion28 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GliosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Schur, MD, MS, University of Washington
- Investigators
- Ellen A Schur, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626907
- Sponsor's protocol ID
- STUDY00015328
- Other IDs
- 1R01DK133356-01
- Acronym
- WYE
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2022
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Diet on Hypothalamic Gliosis in Humans
- ClinicalTrials.gov ID
- NCT05626907
- Acronym / sponsor ID
- WYE / STUDY00015328
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Posted 17 Jul 2026
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 use magnetic resonance imaging (MRI) to evaluate the human hypothalamus for signs of inflammation in response to specific diets. This research may lead to a better understanding of how poor nutritional quality may lead to obesity through effects on regions of the brain known to regulate body weight.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Assigned Diet #1 | Experimental | Other: Diet modification #1 |
| Assigned Diet #2 | Experimental | Other: Diet modification #2 |
| Assigned Diet #3 | Other | Other: Diet modification #3 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-40 years
- Overweight: BMI 25-29.9 kg/m2
- Willing to undergo randomly assigned 14-day diet modification
Key exclusion criteria (13 listed)
- History of bariatric surgery or active participation in weight-loss program
- Major medical or neurological disorder (e.g., diabetes, multiple sclerosis)
- Anemia or impaired kidney or liver function
- Known gallbladder disease or gallstones
- Hypertriglyceridemia (>350 mg/dl)
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 |
|---|---|---|
| Diet modification #1Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 130% of estimated daily caloric needs and for the other 7 days, meals will be low in calories, consistent with recommendations for weight loss. | Other | Assigned Diet #1 |
| Diet modification #2Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 150% of estimated daily caloric needs and for the other 7 days, meals will be meals will be low in calories, consistent with recommendations for weight loss. | Other | Assigned Diet #2 |
| Diet modification #3Participants will be provided all meals for a 14-day period to be approximately 100% of estimated daily caloric needs. | Other | Assigned Diet #3 |
Primary outcome
Hypothalamic Gliosis
Time frame: 7 days of diet intervention
T2 relaxation time as measured by brain MRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ellen A Schur, MD, MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet modification #1, Diet modification #2 and Diet modification #3 in people with Gliosis and Obesity, run by University of Washington 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 13 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 17 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hypothalamic Gliosis (time frame: 7 days of diet intervention). 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 17 Jul 2026.