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ObesityFoodBATNCT06285461

Food Intake, Endocrine Factors and Brown Fat

A study testing Non-palatable meal and Palatable meal in people with Obesity, run by Turku University Hospital at 1 site in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Non-palatable meal and Palatable meal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFinland
Study dates
20 Feb 2024to 30 Jun 2027
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • 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).

Who cannot join

  • • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Turku PET Centre

    Turku, 20520

Other trials in Finland

About this study

Official title: 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).

Read the 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.

Conditions
Obesity
Being tested
Non-palatable meal, Palatable meal
Keywords
Brown adipose tissue, Gut peptides, Meal-induced thermogenesis, Gut-BAT-brain axis
Medical subject headings
Obesity

What participants receive

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

  • Non-palatable mealBehavioural

    Also called low-hedonic reward

    Participants will consume a meal that corresponds to 40% of their daily resting metabolic rate and balanced diet but with low hedonic reward.

  • Palatable mealBehavioural

    Also called high-hedonic reward

    Participants will consume a meal that corresponds to 40% of their daily resting metabolic rate and balanced diet but with high-hedonic reward.

Study groups in NCT06285461
Study groupRoleWhat they receive
Non-palatable mealExperimentalAcute 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.
Receives: Behavioral: Non-palatable meal
PalatableExperimentalAcute 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.
Receives: Behavioral: Palatable meal

What is being measured

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

  1. Brown adipose tissue metabolism

    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.

    Measured: Fasting and postprandial (30 minutes after the consumption of two different meals, 2 weeks of washout between them)

  2. Changes in gut peptides

    Changes in gut peptides (secretin, GIP, GLP-1) from fasting to postprandial state (after intake of meals with high- or low-hedonic reward).

    Measured: Fasting and postprandial (30, 60, 90, and 120 minutes after meal intake)

  3. Differences in μ-opioid receptors in the human brain

    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.

    Measured: 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 outcomes (2)

  1. Energy expenditure/Meal-induced thermogenesis

    Changes in energy expenditure (from indirect calorimetry) after the intake of the two meals will be compared.

    Measured: Changes in energy expenditure after food intake (30 minutes, 1 hour 30 minutes and 2 hours 30 minutes after food intake)

  2. Visual Analogue scale (VAS)

    Changes in VAS after food intake compared to fasting

    Measured: Fasting, 30, 60, 90, and 120 minutes after food intake

Timeline

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

  1. First posted29 Feb 2024
  2. Study start20 Feb 2024
  3. Primary completion10 Mar 2026
  4. Study completion30 Jun 2027 (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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
This will be a crossover study in which participants undergo two postprandial test days with meals with high- or low-hedonic reward and two weeks of washout between interventions.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06285461
Sponsor's protocol ID
T2566/2023
Acronym
FoodBAT
Status last verified
Apr 2026
First submitted
15 Feb 2024
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Non-palatable meal and Palatable meal in people with Obesity, run by Turku University Hospital at 1 site in Finland.

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 4 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 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 Finland. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brown adipose tissue metabolism (time frame: Fasting and postprandial (30 minutes after the consumption of two different meals, 2 weeks of washout between them)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06285461.

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 14 Apr 2026.

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