Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078345
Status:
RECRUITING
Last Update Posted:
2023-11-01
First Post:
2023-10-05
Brief Title:
Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis
Status:
RECRUITING
Status Verified Date:
2023-10
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:
BANDIT
Brief Summary:
To test the hypothesis that active BAT improves metabolic health by buffering postprandial metabolites plasma metabolites and energy expenditure will be compared in volunteers with and without active BAT Both groups will receive test meals with protein fat and carbohydrates separately so that the individual impacts of these macronutrients on diet induced thermogenesis and the buffering function of BAT can be derived BAT biopsies will be taken before and after the test meals for molecular analysis
Detailed Description:
In this prospective interventional study healthy individuals will be screened for presence of active BAT Maximal BAT activity will be achieved by a mild cold stimulus over 2 hous and quantified by 18F-FDG-PETCT 30 min after injection of 75 MBq of 18F-FDG
Individuals with FDG-PET positive BAT will be included as BAT-positive subjects n15 and individuals with absence of FDG-positive BAT will be included as BAT-negative subjects n15 and then take part in three study visits in random order
During the study visits participants will consume a standardized isocaloric liquid meal consisting of A glucose OGTT B fat and C protein
Energy expenditure will be measured by indirect calorimetry before as well as hourly after the meal for 5 hours Blood samples will be taken before and at 30 minute intervals after the meal for 5 hours for analysis of blood glucose triglycerides FAAs representative amino acids insulin and noradrenaline
Subjects will undergo ultrasound-guided biopsy of the supraclavicular fat depot in the fasting state and after one of the test meals so that biopsies from 5 individuals in each group after each test meal will be obtained
Individuals with FDG-PET positive BAT will be included as BAT-positive subjects n15 and individuals with absence of FDG-positive BAT will be included as BAT-negative subjects n15 and then take part in three study visits in random order
During the study visits participants will consume a standardized isocaloric liquid meal consisting of A glucose OGTT B fat and C protein
Energy expenditure will be measured by indirect calorimetry before as well as hourly after the meal for 5 hours Blood samples will be taken before and at 30 minute intervals after the meal for 5 hours for analysis of blood glucose triglycerides FAAs representative amino acids insulin and noradrenaline
Subjects will undergo ultrasound-guided biopsy of the supraclavicular fat depot in the fasting state and after one of the test meals so that biopsies from 5 individuals in each group after each test meal will be obtained
Study Oversight
Has Oversight DMC:
None
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?:
None