Food Intake, Endocrine Factors and Brown Fat (FoodBAT)

April 9, 2026 updated by: Kirsi Virtanen, Turku University Hospital

Understanding the Role of Food Intake and Endocrine Factors in Brown Adipose Tissue Function

This study will investigate how the acute intake of foods with high and low hedonic reward differentially affects brown adipose tissue and the interplay between gut peptides, brown fat, and the brain (gut-BAT-brain axis).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: The prevalence of obesity is alarmingly high and contributes to the dysfunction of other metabolic organs and tissues, increasing the risk of cardiometabolic diseases. Food products rich in sugar, sodium, and saturated fatty acids, i.e., with high hedonic reward, are shown to disrupt energy homeostasis by overriding the homeostatic control of food intake, promoting body weight gain. Contrary to white adipose tissue, brown adipose tissue uses glucose and triglycerides as fuel to dissipate energy as heat and has been considered an essential target for combating obesity. Recently, it has been shown that meal-induced thermogenesis (MIT) is associated with BAT function and that the postprandial secretion of secretin plays a role in BAT activation and satiety. Therefore, we hypothesize that foods with different degrees of hedonic reward (i.e high-palatable foods) affect the gut-BAT-brain axis, modulating energy homeostasis. Moreover, it differentially affects lean and obese individuals. Methods: This crossover clinical trial consists of two acute postprandial tests (low versus high-hedonic reward meals) with two weeks of washout. Thirty participants (15 lean and 15 with overweight/obesity) will undergo PET/CT scans with short-living radiotracers ([15O]-O2, [15O]-H2O PET/CT) before and after consumption of the two test meals to analyze BAT function. After food intake, one [11C]-carfentanil PET/CT will be carried out to understand the role of the brain in the gut-brain-BAT axis. Before and after the test meal, energy expenditure (indirect calorimetry) and circulating gut peptides will be analyzed to investigate the interplay between gut and BAT. The effect of organoleptic cues on the gut peptides and BAT will also be examined. Participants will answer dietary, behavioral, and physical activity questionnaires at the start of their participation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kirsi A Virtanen, Professor
  • Phone Number: +358 407626564
  • Email: kianvi@utu.fi

Study Contact Backup

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Turku PET Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Males and females

    • Between 18 and 45 years old.
    • For the lean group: BMI<25.0 kg/m2
    • For the group with overweight/obesity: BMI>27.5 kg/m2 and a waist circumference of over 94 cm (men) or 80 cm (women).

Exclusion Criteria:

  • • Inability to have PET/CT (claustrophobia, weight > 150 kg);

    • Pregnancy and pregnancy-related conditions (postpartum/lactation during the last 12 months, or planning to become pregnant soon);
    • Major alterations in the menstrual cycle (e.g., amenorrhea);
    • Use of nicotine-based products;
    • Hypo- or hyper- thyroidism (medical history, TSH, T3 or T4 levels out of the normal range);
    • Diabetes mellitus (fasting Hb1Ac >6.5% or fasting glycaemia>125 mg/dL) or abnormal oral glucose tolerance test (2h OGTT > 7.8 mmol/L);
    • Hypertension (blood pressure > 160/100 mmHg) or abnormal cardiovascular status (arrhythmia and/or long QTc in ECG, abnormal cardiac murmur, previous history of cardiovascular disease);
    • Abnormal coagulopathy (e.g., clotting abnormality);
    • Malignancies, immunological, autoimmune and primary/secondary immunodeficiency disorders (including or not any active treatment).
    • Virus or bacterial infection (both asymptomatic and symptomatic picture) within the 30 days prior to the study start;
    • Episode of fever or major surgery, burns and traumas within the month prior to the study start
    • Chronic infections requiring chronic antibiotic or anti-viral treatment
    • Whole blood donation in the last 3 months (>400 mL of blood) or plans for blood donation during the entire protocol period
    • Weight change (intentional or not) over the last 6-months > than 5% of body weight, or plan to lose weight during the study,
    • Use of any medication that, in the opinion of local clinician/researcher, would negatively affect or mitigate full participation and completion, or could influence the study results. This especially applies to the use of β or α adrenergic receptors agonists/antagonists (e.g., β-blockers). In addition, participants in use of medication for glucose control or weight loss such as GLP-1 analogs will not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Non-palatable meal
Acute intake of a non-palatable meal, i.e., with low-hedonic reward, followed by PET/CT scans with three different radiotracers ([15O]H2O, [15O] oxygen, and [11C]-carfentanil.
Behavioral: Non-palatable meal
Participants will consume a meal that corresponds to 40% of their daily resting metabolic rate and balanced diet but with low hedonic reward.
Other Names:
  • low-hedonic reward
Experimental: Palatable
Acute intake of a palatable meal, i.e., with high-hedonic reward, followed by PET/CT scans with three different radiotracers ([15O]H2O, [15O] oxygen, and [11C]-carfentanil.
Behavioral: Palatable meal
Participants will consume a meal that corresponds to 40% of their daily resting metabolic rate and balanced diet but with high-hedonic reward.
Other Names:
  • high-hedonic reward

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brown adipose tissue metabolism
Time Frame: Fasting and postprandial (30 minutes after the consumption of two different meals, 2 weeks of washout between them)
Brown adipose tissue metabolism will be assessed using 15O-O2 and 15O-H2O PET/CT, at room temperature, at fasting, after food cues, and after food intake.
Fasting and postprandial (30 minutes after the consumption of two different meals, 2 weeks of washout between them)
Changes in gut peptides
Time Frame: Fasting and postprandial (30, 60, 90, and 120 minutes after meal intake)
Changes in gut peptides (secretin, GIP, GLP-1) from fasting to postprandial state (after intake of meals with high- or low-hedonic reward).
Fasting and postprandial (30, 60, 90, and 120 minutes after meal intake)
Differences in μ-opioid receptors in the human brain
Time Frame: The 11C-carfentanil binding potential (BP) will be analyzed 45 minutes after the consumption of the two meals (high or low-hedonic reward). The comparisons will be between the two meals.
Differences in the brain's μ-opioid receptor (MOR) system (11C-carfentanil binding potential - BP). The differences between the two meals on 11C-carfentanil BP will be analyzed.
The 11C-carfentanil binding potential (BP) will be analyzed 45 minutes after the consumption of the two meals (high or low-hedonic reward). The comparisons will be between the two meals.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Energy expenditure/Meal-induced thermogenesis
Time Frame: Changes in energy expenditure after food intake (30 minutes, 1 hour 30 minutes and 2 hours 30 minutes after food intake)
Changes in energy expenditure (from indirect calorimetry) after the intake of the two meals will be compared.
Changes in energy expenditure after food intake (30 minutes, 1 hour 30 minutes and 2 hours 30 minutes after food intake)
Visual Analogue scale (VAS)
Time Frame: Fasting, 30, 60, 90, and 120 minutes after food intake
Changes in VAS after food intake compared to fasting
Fasting, 30, 60, 90, and 120 minutes after food intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Turku University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Turku

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Milena Monfort-Pires, PhD, University of Turku
  • Principal Investigator: Kirsi A Virtanen, Professor, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T2566/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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