Active, not recruitingNot applicableInterventional
What this study is about
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).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 45 Years
SexAll
Healthy volunteersAccepted
ConditionObesity
Full registry criteria
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.
Primary outcomes
Brown adipose tissue metabolismFasting 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.
Changes in gut peptidesFasting 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).
Differences in μ-opioid receptors in the human brainThe 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.
