GliosisBRIDGENCT06870578
Building Research for Intervention Development in Gliosis and Eating Habits
A study testing Diet modification in people with Gliosis and Child Obesity, run by University of Washington at 1 site in United States.
Trial summary
The goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gliosis, Child Obesity, Eating
- What is being tested?
- Diet modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Study1: Adult caregiver and Child age 9-11y. Willing to come to in-person focus group
- Study 2: Age 9-11y, BMI ≥85th and ≤95th percentile for age and sex
- Study 3:Adult caregiver with child who qualify for free or reduced-cost lunch in WA State. Child age 9-11y and with overweight.
- Exclusion Criteria (study 1 child participants and study 3 criteria for children of adult participants):
- Significant health conditions including type 2 diabetes
- History of major weight loss or eating disorder
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- Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
- Documented cognitive disorder
- Severe food allergies, vegetarian, or vegan (Study 1 only)
- Unable to make the session date
Who cannot join
- Significant health conditions including type 2 diabetes
- History of major weight loss or eating disorder
- Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
- Documented cognitive disorder
- MRI contraindication (e.g., braces, claustrophobia)
- Weight >330 pounds (MRI limit)
- Severe food allergies, vegetarian, or vegan
- Currently in formal weight loss program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98109
BRIDGE Study, 206-616-6360, bridge-study@uw.edu
About this study
Official title: Fostering Patient-oriented Research in Cardiometabolic Disease Pathogenesis and Prevention
The goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity.
- Conditions
- Gliosis, Child Obesity, Eating
- Being tested
- Diet modification
- Medical subject headings
- Gliosis, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet modificationOther
In Study 2 only, children will be provided all meals for a 7-day period. Meals will consist of nutritious foods, calories provided will exceed the child's estimated daily caloric need, and children will be asked to consume meals ad libitum.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group and Child Taste Test (Study 1) | No intervention | No intervention is administered. Adult caregivers will participate in a focus group to assess feasibility of a controlled feeding study in children and children will complete a taste-test of a controlled feeding study menu. |
| Study-provided food (Study 2) | Experimental | Participants will be provided all meals for a 7-day period. For the other 7-days of their enrollment, they will be asked to consume their usual diet. Receives: Other: Diet modification |
| Focus Group (Study 3) | No intervention | No intervention is administered. Adult caregivers of children will participate in a focus group to learn from families about participating in research involving feeding studies in children. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2 relaxation time 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 posted11 Mar 2025
- Study start3 Apr 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ellen Schur, MD, MS, University of Washington
- Investigators
- Ellen Schur, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870578
- Sponsor's protocol ID
- STUDY00020281
- Other IDs
- 2K24HL144917
- Acronym
- BRIDGE
- Status last verified
- Jun 2025
- First submitted
- 28 Feb 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Patient-oriented Research in Cardiometabolic Disease Pathogenesis and Prevention
- ClinicalTrials.gov ID
- NCT06870578
- Acronym / sponsor ID
- BRIDGE / STUDY00020281
- Conditions
- Gliosis, Child Obesity, Eating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 11 Mar 2025 (actual)
- 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 goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus Group and Child Taste Test (Study 1) | No intervention | –No intervention is administered. Adult caregivers will participate in a focus group to assess feasibility of a controlled feeding study in children and children will complete a taste-test of a controlled feeding study menu. |
| Study-provided food (Study 2) | Experimental | Other: Diet modificationParticipants will be provided all meals for a 7-day period. For the other 7-days of their enrollment, they will be asked to consume their usual diet. |
| Focus Group (Study 3) | No intervention | –No intervention is administered. Adult caregivers of children will participate in a focus group to learn from families about participating in research involving feeding studies in children. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Study1: Adult caregiver and Child age 9-11y. Willing to come to in-person focus group
- Study 2: Age 9-11y, BMI ≥85th and ≤95th percentile for age and sex
- Study 3:Adult caregiver with child who qualify for free or reduced-cost lunch in WA State. Child age 9-11y and with overweight.
- Exclusion Criteria (study 1 child participants and study 3 criteria for children of adult participants):
- Significant health conditions including type 2 diabetes
Key exclusion criteria (8 listed)
- Significant health conditions including type 2 diabetes
- History of major weight loss or eating disorder
- Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
- Documented cognitive disorder
- MRI contraindication (e.g., braces, claustrophobia)
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 modificationIn Study 2 only, children will be provided all meals for a 7-day period. Meals will consist of nutritious foods, calories provided will exceed the child's estimated daily caloric need, and children will be asked to consume meals ad libitum. | Other | Study-provided food (Study 2) |
Primary outcome
T2 relaxation time by brain MRI
Time frame: 7 days of diet intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- 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.
Ellen Schur, MD 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 in people with Gliosis and Child 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 10 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BRIDGE Study (206 616-6360, bridge-study@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2 relaxation time by brain MRI (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 6 Jun 2025.