Clinical trial NCT06724692: Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals
Official title: Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glucocorticoids
Obesity and Overweight
Food Effect
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, monocentric, cross-over, open-label study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Blood cortisol change
timeFrame: Up to six weeks
Secondary outcomes:
measure: Energy expenditure (basal metabolic rate, diet-induced thermogenesis
timeFrame: Up to six weeks
measure: Substrate utilization (respiratory quotient)
timeFrame: Up to six weeks
measure: Body composition
timeFrame: Up to six weeks
measure: Satiety
timeFrame: Up to six weeks
measure: Weight
timeFrame: Up to six weeks
measure: Motivation to eat
timeFrame: Up to six weeks
measure: Systolic and diastolic blood pressure
timeFrame: Up to six weeks
measure: Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides)
timeFrame: Up to six weeks
measure: Perceived stress
timeFrame: Up to six weeks
measure: C-peptide
timeFrame: Up to six weeks
measure: Insulin
timeFrame: Up to six weeks
measure: Blood glucose
timeFrame: Up to six weeks
measure: Neuroendocrine hormones (thyroid hormones, GLP1, glucagon, ACTH)
timeFrame: Up to six weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: Sponsor and principal investigator
name: Eleonora Seelig, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: