Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 5:11 PM
Study NCT ID:
NCT06285461
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Intake, Endocrine Factors and Brown Fat
Sponsor:
Turku University Hospital
Organization:
Study Overview
Official Title:
Understanding the Role of Food Intake and Endocrine Factors in Brown Adipose Tissue Function
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FoodBAT
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: