Brain Dopamine Dynamics in Obesity
NCT07915986, Phase 1, Not yet recruiting, Yale University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Brain Dopamine Dynamics in Obesity | ClinicalTrials.gov |
| NCT number | NCT07915986 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Yale University | ClinicalTrials.gov |
| Conditions | Obesity | ClinicalTrials.gov |
| Interventions | Milkshake, NeuroEXPLORER, [11C]raclopride | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Dopamine (DA) release | 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. | Orosensory and post-ingestive DA release in the ventral and dorsal striatum during and after milkshake consumption | ClinicalTrials.gov |
| Primary | Time to onset of DA peaks | 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). | Time to onset of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum | ClinicalTrials.gov |
| Primary | Duration of DA peaks | 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). | Duration of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum | ClinicalTrials.gov |
| Primary | Time to onset of DA peaks between men and women | 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). | Time to onset of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum | ClinicalTrials.gov |
| Primary | Duration of DA peaks between men and women | 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). | Duration of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum | ClinicalTrials.gov |
| Primary | Magnitude of DA release between men and women | 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). | Magnitude of orosensory and post-ingestive DA peaks in the ventral and dorsal striatum | ClinicalTrials.gov |
| Secondary | Glucose | 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. | 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. | ClinicalTrials.gov |
| Secondary | Insulin | 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. | 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. | ClinicalTrials.gov |
| Secondary | FFA | 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. | 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. | ClinicalTrials.gov |
| Secondary | Gut peptides (tbd) | 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. | 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. | ClinicalTrials.gov |
| Secondary | Yale Food Addiction Scale 2.0 score | 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 | Total score ranges from 0 to 11. Higher symptom counts indicate more symptoms of addictive-like eating. | ClinicalTrials.gov |
| Secondary | Barratt Impulsiveness Scale (BIS-11) score | 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 | 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. | ClinicalTrials.gov |
| Secondary | Dietary Fat and Free Sugar - Short Questionnaire (DFS) | 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 | 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. | ClinicalTrials.gov |
| Secondary | Change in Delay Discounting Task | 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) | 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. | ClinicalTrials.gov |
| Secondary | Change in Iowa Gambling Task score | 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) | 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. | ClinicalTrials.gov |
| Secondary | Behavioral Inhibition System/Behavioral Activation System Scale score | 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 | 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. | ClinicalTrials.gov |
| Secondary | Change in Visual Analogue Scale (VAS) score | 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) | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01DK144194 | Brain Dopamine Dynamics in Obesity | Serlie, Mireille Johanna | YALE UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2026 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Delay Discounting | Secondary outcome | ConductCognition |
| Iowa Gambling Lite | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)