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Brain Dopamine Dynamics in Obesity (BDDO)

28 ottobre 2026 aggiornato da: Mireille Serlie, Yale University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
        • Yale School of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Adults with obesity

Four visits per participant: screening, PET practice session, MRI+behavioral assessment, milkshake+PET scan.
Altro: Milkshake

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

Dispositivo: NeuroEXPLORER

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

Altri nomi:
  • Ultra high resolution PET scan
Droga: [11C]raclopride

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.

Altri nomi:
  • iniezione
Sperimentale: Adults with normal weight

Four visits per participant: screening, PET practice session, MRI+behavioral assessment, milkshake+PET scan.
Altro: Milkshake

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

Dispositivo: NeuroEXPLORER

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

Altri nomi:
  • Ultra high resolution PET scan
Droga: [11C]raclopride

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.

Altri nomi:
  • iniezione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dopamine (DA) release
Lasso di tempo: 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
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.
Time to onset of DA peaks
Lasso di tempo: 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
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 DA peaks
Lasso di tempo: 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
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 DA peaks between men and women
Lasso di tempo: 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
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 DA peaks between men and women
Lasso di tempo: 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
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 DA release between men and women
Lasso di tempo: 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
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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Glucose
Lasso di tempo: 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.
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.
Insulin
Lasso di tempo: 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.
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.
FFA
Lasso di tempo: 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.
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.
Gut peptides (tbd)
Lasso di tempo: 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.
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.
Yale Food Addiction Scale 2.0 score
Lasso di tempo: 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.
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
Barratt Impulsiveness Scale (BIS-11) score
Lasso di tempo: 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.
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
Dietary Fat and Free Sugar - Short Questionnaire (DFS)
Lasso di tempo: 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.
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
Change in Delay Discounting Task
Lasso di tempo: 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.
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)
Change in Iowa Gambling Task score
Lasso di tempo: 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.
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)
Behavioral Inhibition System/Behavioral Activation System Scale score
Lasso di tempo: 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.
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
Change in Visual Analogue Scale (VAS) score
Lasso di tempo: 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
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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Yale University

Collaboratori

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigatori

  • Investigatore principale: Mireille Serlie, MD PhD, Yale University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 novembre 2029

Completamento dello studio (Stimato)

1 novembre 2029

Date di iscrizione allo studio

Primo inviato

15 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2000042630
  • 1R01DK144194-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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