GlucocorticoidsUltraCortNCT06724692
Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals
A study testing Ultra-processed breakfast and Low-processed breakfast in people with Glucocorticoids and Obesity and Overweight, run by Eleonora Seelig at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucocorticoids, Obesity and Overweight, Food Effect
- What is being tested?
- Ultra-processed breakfast and Low-processed breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Oct 2024to 4 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 18 to 40 years
- BMI 18.5-29.9 kg/m2
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
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.
Read the 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
- Being tested
- Ultra-processed breakfast, Low-processed breakfast
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-processed breakfastOther
With this intervention, participants will consume ultra-processed foods
Low-processed breakfastOther
With this intervention, participants will consume low-processed foods
| Study group | Role | What they receive |
|---|---|---|
| Ultra-processed breakfast | Active comparator | During one study phase, subjects receive an ultra-processed breakfast Receives: Other: Ultra-processed breakfast |
| Low-processed breakfast | Active comparator | During the other study phase, subjects receive a low-processed breakfast Receives: Other: Low-processed breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood cortisol change
Change in blood cortisol assessed by repeadidly collecting blood before and after the meal
Measured: Up to six weeks
Secondary outcomes (13)
Energy expenditure (basal metabolic rate, diet-induced thermogenesis
Basal metabolic rate measured with indirect calorimetry
Measured: Up to six weeks
Substrate utilization (respiratory quotient)
Respiratory quotient assessed with indirect calorimetry
Measured: Up to six weeks
Body composition
Body impedance analysis before meal
Measured: Up to six weeks
Satiety
Appetite rating with visual analogue scale (VAS) from 0mm-100mm (0mm=not at all and 100mm=extreme)
Measured: Up to six weeks
Weight
Measurement of weight with a standard scale
Measured: Up to six weeks
Motivation to eat
Motivation to eat measured with a speed clicking test
Measured: Up to six weeks
Systolic and diastolic blood pressure
Assessment of blood pressure with a standard blood pressure monitor
Measured: Up to six weeks
Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides)
Blood collection fasted
Measured: Up to six weeks
Perceived stress
Measured by perceived stress questionnaire
Measured: Up to six weeks
C-peptide
Change in blood cortisol assessed by repeadidly collecting blood before and after the meal
Measured: Up to six weeks
Insulin
Change in blood cortisol assessed by repeadidly collecting blood before and after the meal
Measured: Up to six weeks
Blood glucose
Change in blood glucose assessed by repeadidly collecting blood before and after the meal
Measured: Up to six weeks
Neuroendocrine hormones (thyroid hormones, GLP1, glucagon, ACTH)
Change in blood cortisol assessed by repeadidly collecting blood before and/or after the meal
Measured: Up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start30 Oct 2024
- Primary completion4 Jul 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlucocorticoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, monocentric, cross-over, open-label study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleonora Seelig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eleonora Seelig, University Hospital, Basel, Switzerland
- Investigators
- Eleonora Seelig, PD Dr. med., Principal investigator, Sponsor and principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724692
- Sponsor's protocol ID
- EKNZ 2024-01796
- Acronym
- UltraCort
- Status last verified
- Oct 2025
- First submitted
- 27 Sep 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06724692
- Acronym / sponsor ID
- UltraCort / EKNZ 2024-01796
- Conditions
- Glucocorticoids, Obesity and Overweight, Food Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eleonora SeeligUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, monocentric, cross-over, open-label study
| Arm | Type | Receives |
|---|---|---|
| Ultra-processed breakfast | Active comparator | Other: Ultra-processed breakfastDuring one study phase, subjects receive an ultra-processed breakfast |
| Low-processed breakfast | Active comparator | Other: Low-processed breakfastDuring the other study phase, subjects receive a low-processed breakfast |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males aged 18 to 40 years
- BMI 18.5-29.9 kg/m2
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-processed breakfastWith this intervention, participants will consume ultra-processed foods | Other | Ultra-processed breakfast |
| Low-processed breakfastWith this intervention, participants will consume low-processed foods | Other | Low-processed breakfast |
Primary outcome
Blood cortisol change
Time frame: Up to six weeks
Change in blood cortisol assessed by repeadidly collecting blood before and after the meal
13 secondary outcomes
Energy expenditure (basal metabolic rate, diet-induced thermogenesis
Time frame: Up to six weeks
Substrate utilization (respiratory quotient)
Time frame: Up to six weeks
Body composition
Time frame: Up to six weeks
Satiety
Time frame: Up to six weeks
Weight
Time frame: Up to six weeks
Motivation to eat
Time frame: Up to six weeks
Systolic and diastolic blood pressure
Time frame: Up to six weeks
Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides)
Time frame: Up to six weeks
Perceived stress
Time frame: Up to six weeks
C-peptide
Time frame: Up to six weeks
Insulin
Time frame: Up to six weeks
Blood glucose
Time frame: Up to six weeks
Neuroendocrine hormones (thyroid hormones, GLP1, glucagon, ACTH)
Time frame: Up to six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleonora Seelig, PD Dr. med. principal investigator
Sponsor and principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-processed breakfast and Low-processed breakfast in people with Glucocorticoids and Obesity and Overweight, run by Eleonora Seelig at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood cortisol change (time frame: Up to six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.