AzTrials
AzTrials

ObesityPhase 1BDDONCT07915986

Brain Dopamine Dynamics in Obesity

A Phase 1 study testing Milkshake, NeuroEXPLORER and [11C]raclopride in people with Obesity, run by Yale University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study measures the brain's dopamine response to milkshake consumption in people with a healthy weight and people with obesity and examines whether this response differs between the two groups. Read more about this study

Who is it for?
Ages 50 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Milkshake, NeuroEXPLORER and [11C]raclopride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
Nov 2026to Nov 2029
Phase
Phase 1
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 50 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI 20-25 kg/m² (normal weight group) or BMI 30-45 kg/m² (obesity group)
  • Stable body weight in the 3 months prior to enrollment (<5%weight change)
  • Male sex or postmenopausal female (defined as cessation of menstrual periods for ≥12 consecutive months or FSH >25.8 mIU/mL)
  • Able to read, write, and speak English
  • Capable of giving informed consent

Who cannot join

  • Premenopausal status in women
  • Smoking (current use of any tobacco or nicotine products)
  • History of or current psychiatric disorder
  • History of or current neurological disorder
  • History of bleeding disorder or use of anticoagulants
  • History of or current eating disorder (Eating Disorder Examination Questionnaire)
Show all 27Show fewer
  • Presence of type 1 or type 2 diabetes mellitus
  • Elevated liver enzymes (>2× the upper limit of normal)
  • Renal insufficiency (eGFR <15 mL/min/1.73m²)
  • Anemia and/or Hematocrit <35 vol%
  • Uncontrolled thyroid disease
  • Lactose intolerance
  • Current use of systemic hormone therapy, including oral, transdermal, or injectable estrogen or combined estrogen-progestogen preparations
  • Radiation exposure for research purposes within the past year such that participation in this study would place them over guideline limits for annual radiation exposure (an effective dose of 5 rem received per year).
  • Current, past or anticipated exposure to radiation in the workplace within one year
  • Presence of any somatic disorder or medication use that interferes with brain functional networks or metabolic response to food
  • Shift work
  • Current use of cannabis (any form), cocaine, amphetamines, or other recreational substances with known dopaminergic effects
  • Heavy alcohol use, defined as >15 standard drinks per week for men or >8 standard drinks per week for women (National Institute on Alcohol Abuse and Alcoholism thresholds)
  • Contraindications for MRI: metal implants incompatible with MRI, claustrophobia, large colored tattoos, or body weight >285 pounds
  • Pacemaker in situ or other implanted electronic device
  • Childhood-onset obesity (onset before age 10 years)
  • Current or past (within last year prior to enrollment) pharmacological obesity treatment
  • Past surgical obesity treatment (bariatric surgery)
  • Current use of structured meal replacement programs
  • Blood donation within 8 weeks prior to study
  • Active oral or perioral conditions that may alter taste perception or compromise safety during gustometer use

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mireille Serlie, MD PhD contact

2037375538

mireille.serlie@yale.edu

Elizabeth Sanchez Rangel, MD contact

203-785-6430

elizabeth.sanchezrangel@yale.edu

United States1 site
  • Yale School of Medicine

    New Haven, Connecticut, 06520

Other trials in United States

About this study

This study measures the brain's dopamine response to milkshake consumption in people with a healthy weight and people with obesity and examines whether this response differs between the two groups. Dopamine release will be measured using ultra-high-resolution positron emission tomography (PET) imaging with the NeuroEXPLORER scanner. The study will also examine how the dopamine response relates to hormonal responses measured at the same time and to participants' food intake behavior.

Read the detailed description

This study aims to address three key questions: (1) whether the two phases of dopamine release in the striatum, a brain region involved in reward and motivation, during and after milkshake consumption differ between people with a healthy weight and people with obesity, and between men and women; (2) how metabolic and hormonal responses relate to dopamine release; and (3) whether dopamine-related networks outside the striatum differ between weight groups and predict eating behavior. These findings may improve our understanding of overeating and obesity and help inform the development of treatments that target the brain's dopamine system.

Each participant will complete four visits:

  1. Informed consent and screening to determine eligibility.
  2. A practice session to become familiar with PET scanning and the device used to deliver the milkshake.
  3. An MRI scan and assessments of eating behavior.
  4. A PET scan to measure dopamine release before and during milkshake delivery, with blood samples collected before and during the scan and questionnaires and tasks completed before and after the scan.
Conditions
Obesity
Being tested
Milkshake, NeuroEXPLORER, [11C]raclopride
Keywords
obesity, dopamine, striatum, PET
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MilkshakeOther

    Strawberry, banana, chocolate, or vanilla flavored, delivered through a gustometer during the practice session and PET scan.

  • NeuroEXPLORERDevice

    Also called Ultra high resolution PET scan

    A next-generation ultra-high-performance dedicated human brain PET scanner.

  • [11C]racloprideDrug

    Also called injection

    Carbon-11 radiolabeled PET ligand with high affinity and selectivity for postsynaptic dopamine receptors; one of the standard radiotracers for measuring dopamine release in humans.

Study groups in NCT07915986
Study groupRoleWhat they receive
Adults with obesityExperimentalFour visits per participant: screening, PET practice session, MRI+behavioral assessment, milkshake+PET scan.
Receives: Other: Milkshake; Device: NeuroEXPLORER; Drug: [11C]raclopride
Adults with normal weightExperimentalFour visits per participant: screening, PET practice session, MRI+behavioral assessment, milkshake+PET scan.
Receives: Other: Milkshake; Device: NeuroEXPLORER; Drug: [11C]raclopride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dopamine (DA) release

    Orosensory and post-ingestive DA release in the ventral and dorsal striatum during and after milkshake consumption

    Measured: Visit 4, approximately week 4. Baseline D2/3R binding potential will be assessed at T=30'. PET time-activity curves are then measured continuously for 60 minutes from milkshake onset.

  2. Time to onset of DA peaks

    Time to onset of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum

    Measured: Visit 4, approximately week 4. PET time-activity curves are measured continuously for 60 minutes from milkshake onset (30-90 minutes after initiation of radiotracer administration).

  3. Duration of DA peaks

    Duration of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum

    Measured: Visit 4, approximately week 4.PET time-activity curves are measured continuously for 60 minutes from milkshake onset (30-90 minutes after initiation of radiotracer administration).

  4. Time to onset of DA peaks between men and women

    Time to onset of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum

    Measured: Visit 4, approximately week 4. PET time-activity curves are measured continuously for 60 minutes from milkshake onset (30-90 minutes after initiation of radiotracer administration).

  5. Duration of DA peaks between men and women

    Duration of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum

    Measured: Visit 4, approximately week 4. PET time-activity curves are measured continuously for 60 minutes from milkshake onset (30-90 minutes after initiation of radiotracer administration).

  6. Magnitude of DA release between men and women

    Magnitude of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum

    Measured: Visit 4, approximately week 4. PET time-activity curves are measured continuously for 60 minutes from milkshake onset (30-90 minutes after initiation of radiotracer administration).

Secondary outcomes (11)
  1. Glucose

    To assess the relationship between the metabolic response to the milkshake and striatal dopamine release, we will use a machine learning approach including network analysis.

    Measured: Glucose will be collected after an overnight fast on the morning of the PET scan and at 7.5, 15, 30, and 45 minutes after milkshake onset at Visit 4, approximately week 4.

  2. Insulin

    To assess the relationship between the metabolic response to the milkshake and striatal dopamine release, we will use a machine learning approach including network analysis.

    Measured: Insulin will be collected after an overnight fast on the morning of the PET scan and at 7.5, 15, 30, and 45 minutes after milkshake onset at Visit 4, approximately week 4.

  3. FFA

    To assess the relationship between the metabolic response to the milkshake and striatal dopamine release, we will use a machine learning approach including network analysis.

    Measured: FFA will be collected after an overnight fast on the morning of the PET scan and at 7.5, 15, 30, and 45 minutes after milkshake onset at Visit 4, approximately week 4.

  4. Gut peptides (tbd)

    To assess the relationship between the metabolic response to the milkshake and striatal dopamine release, we will use a machine learning approach including network analysis.

    Measured: Gut peptides will be collected after an overnight fast on the morning of the PET scan and at 7.5, 15, 30, and 45 minutes after milkshake onset.

  5. Yale Food Addiction Scale 2.0 score

    Total score ranges from 0 to 11. Higher symptom counts indicate more symptoms of addictive-like eating.

    Measured: After screening (visit 1), the PET test session (visit 2), the questionnaire will be administered during visit 3 (duration 10 minutes); after completion of the MRI

  6. Barratt Impulsiveness Scale (BIS-11) score

    A 30-item self-report questionnaire designed to measure human impulsiveness as a multidimensional personality and behavioral trait. Total score range 30 to 120, with higher scores reflecting greater impulsiveness.

    Measured: After screening (visit 1), the PET test session (visit 2), the questionnaire will be administered during visit 3 (duration 10 minutes); after completion of the MRI

  7. Dietary Fat and Free Sugar - Short Questionnaire (DFS)

    A 26-item self-report tool to measure how often a person eats foods high in saturated fat and free sugar over the past 12 months. Total score range 26 to 130, with higher scores reflecting more frequent consumption of foods high in saturated fat and/or free sugars.

    Measured: After screening (visit 1), the PET test session (visit 2), the questionnaire will be administered during visit 3 (duration 10 minutes); after completion of the MRI

  8. Change in Delay Discounting Task

    A behavioral assessment (computer task) to determine reward sensitivity (how much a person devalues a reward as the wait time for it increases). Calculated as Discount rate (k). Higher k indicates greater preference for immediate rewards.

    Measured: The task will be administered at the PET Center after an overnight fast at baseline (before radio tracer administration) and after the PET scan at T=105' (duration of the task is 10 minutes)

  9. Change in Iowa Gambling Task score

    The Iowa Gambling Task is a behavioral task that assesses decision-making under uncertainty by asking participants to select cards from four decks with different rewards and losses. The net score is calculated by subtracting the number of selections from disadvantageous decks from the number of selections from advantageous decks.

    Measured: The task will be administered at the PET Center after an overnight fast at baseline (before radio tracer administration) and after the PET scan at T=115' (duration of the task is 15 minutes)

  10. Behavioral Inhibition System/Behavioral Activation System Scale score

    The Behavioral Inhibition System/Behavioral Activation System (BIS/BAS) Scales assess sensitivity to punishment and reward. The questionnaire contains 24 items, including 20 scored items and 4 filler items. It yields four subscale scores: Behavioral Inhibition (7-28), BAS Drive (4-16), BAS Fun Seeking (4-16), and BAS Reward Responsiveness (5-20). Higher scores indicate greater sensitivity to punishment, stronger pursuit of goals, greater fun seeking, and greater responsiveness to reward, respectively.

    Measured: After screening (visit 1), the PET test session (visit 2), the questionnaire will be administered during visit 3 (duration 10 minutes); after completion of the MRI

  11. Change in Visual Analogue Scale (VAS) score

    VAS to assess hunger and satiety on a scale of 0-100. Higher hunger scores indicate greater hunger, while higher satiety/fullness scores indicate greater satiety/fullness

    Measured: The task will be administered at the PET Center after an overnight fast at baseline (before radio tracer administration) and after the PET scan at T=100' (duration of the task is 2 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

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 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study is cross-sectional: each participant undergoes one PET scan, one MRI session, 2 food intake behavior assessment sessions, and a screening visit.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07915986
Sponsor's protocol ID
2000042630
Other IDs
1R01DK144194-01A1
Acronym
BDDO
Status last verified
Oct 2026
First submitted
15 Oct 2026
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Computer codes developed for MRI and PET analysis will be shared on the open-access GitHub platform to support reproducibility. The study protocol and clinical data generated from this study will be uploaded to ClinicalTrials.gov. De-identified neuroimaging and research data will be submitted to appropriate NIH data repositories in compliance with NIH data sharing requirements.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Milkshake, NeuroEXPLORER and [11C]raclopride in people with Obesity, run by Yale University 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 5 inclusion and 27 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: opening soon, as of the sponsor's last update on 4 Nov 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Mireille Serlie, MD PhD (2037375538, mireille.serlie@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dopamine (DA) release (time frame: Visit 4, approximately week 4. Baseline D2/3R binding potential will be assessed at T=30'. PET time-activity curves are then measured continuously for 60 minutes from milkshake onset.). The study lists 6 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 4 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in