Food Intake, Endocrine Factors and Brown Fat

NCT06285461 | Active Not Recruiting

• 1 other identifier: T2566/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity

Keywords

Brown adipose tissue; Gut peptides; Meal-induced thermogenesis; Gut-BAT-brain axis

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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).

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

• 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.

  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)

• Energy expenditure/Meal-induced thermogenesis

  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)

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

Study Arms (2)

Non-palatable meal

EXPERIMENTAL

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

Palatable

EXPERIMENTAL

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

Interventions

Non-palatable meal BEHAVIORAL

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

Also known as: low-hedonic reward

Non-palatable meal

Palatable meal BEHAVIORAL

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

Also known as: high-hedonic reward

Palatable

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

Turku PET Centre

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Milena Monfort-Pires, PhD

  University of Turku

  STUDY DIRECTOR

• Kirsi A Virtanen, Professor

  University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 29, 2024
• Study Start: February 20, 2024
• Primary Completion: March 10, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)