Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
Study NCT ID:
NCT06724692
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2024-09-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals
Sponsor:
Eleonora Seelig
Organization:
Study Overview
Official Title:
Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals
Status:
RECRUITING
Status Verified Date:
2025-03
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:
UltraCort
Brief Summary:
The investigators aim to understand whether the acute cortisol response to food differs between differently processed foods.
In this monocentric, randomized, cross-over, open-label study, 20 healthy volunteers will receive two differently processed meals of similar caloric content and composition. The study will primarily focus on changes in blood cortisol levels, but other metabolic parameters will also be compared.
In this monocentric, randomized, cross-over, open-label study, 20 healthy volunteers will receive two differently processed meals of similar caloric content and composition. The study will primarily focus on changes in blood cortisol levels, but other metabolic parameters will also be compared.
Detailed Description:
Obesity is one of the most serious health problems of the 21st century, with ultra-processed diets being a major driver of the current obesity pandemic. Understanding how these diets affect body weight is critical to identifying new treatment targets. Current evidence suggests that the degree of food processing may affect cortisol secretion, a hormone that plays a key role in body weight regulation by increasing with acute food intake and promoting energy storage in adipose tissue. However, whether ultra-processed foods enhance cortisol response has not been thoroughly investigated.
Here, the investigators aim to understand the reaction of GCs in response to different processed foods in healthy volunteers. No medication will be used in this study.
Participants will be asked to refrain from strenuous physical activity and alcohol consumption for 24 hours prior to the study. They will fast for 12 hours before consuming a high-calorie, low-processed meal. After fasting again, participants will consume a high-calorie, ultra-processed meal on a second study day. The order of the meals is not fixed. The study will include a screening visit and two study visits.
Here, the investigators aim to understand the reaction of GCs in response to different processed foods in healthy volunteers. No medication will be used in this study.
Participants will be asked to refrain from strenuous physical activity and alcohol consumption for 24 hours prior to the study. They will fast for 12 hours before consuming a high-calorie, low-processed meal. After fasting again, participants will consume a high-calorie, ultra-processed meal on a second study day. The order of the meals is not fixed. The study will include a screening visit and two study visits.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: