Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals

NCT ID: NCT06724692

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2026-02-28

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.

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.

Conditions

Glucocorticoids; Obesity and Overweight; Food Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ultra-processed breakfast

During one study phase, subjects receive an ultra-processed breakfast

Group Type: ACTIVE_COMPARATOR

Ultra-processed breakfast

Intervention Type: OTHER

With this intervention, participants will consume ultra-processed foods

Low-processed breakfast

During the other study phase, subjects receive a low-processed breakfast

Group Type: ACTIVE_COMPARATOR

Low-processed breakfast

Intervention Type: OTHER

With this intervention, participants will consume low-processed foods

Interventions

Ultra-processed breakfast

With this intervention, participants will consume ultra-processed foods

Intervention Type: OTHER

Low-processed breakfast

With this intervention, participants will consume low-processed foods

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males aged 18 to 40 years
• BMI 18.5-29.9 kg/m2

Exclusion Criteria

• Severe acute or chronic disease
• Lactose intolerance
• Severe food allergy
• Casual smoking (more than six cigarettes per day)
• Frequent, heavy alcohol consumption (more than 30g/day)
• Frequent, heavy caffeine consumption (more than 4 caffeinated drinks/day)
• Regular physical exercise (more than 4hrs per week)
• Shift work
• Previous enrollment in a clinical trial within the past two months
• Intake of any steroid-containing drugs, including topical steroids and inhalers, within four weeks of the study initiation
• Contradictions to undergo the investigated intervention
• Inability or unwillingness to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eleonora Seelig

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Seelig

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eleonora Seelig, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Sponsor and principal investigator

Locations

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Eleonora Seelig, PD Dr. med.

Role: CONTACT

eleonora.seelig@usb.ch

0041 61 328 63 23

Jil C Chevailler, MD

Role: CONTACT

jilclaire.chevailler@usb.ch

0041613284841

Facility Contacts

Eleonora Seelig, PD Dr. med.

Role: primary

eleonora.seelig@usb.ch

0041 61 328 63 23

Jil C Chevailler, MD

Role: backup

jilclaire.chevailler@usb.ch

0041613284841

Other Identifiers

EKNZ 2024-01796

Identifier Type: -

Identifier Source: org_study_id