Food Effect, Glucocorticoids, Obesity and Overweight
Conditions
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.
Interventions
OTHERUltra-processed breakfast
With this intervention, participants will consume ultra-processed foods
OTHERLow-processed breakfast
With this intervention, participants will consume low-processed foods
Sponsors
Eleonora Seelig
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized, monocentric, cross-over, open-label study
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood cortisol change | Up to six weeks | Change in blood cortisol assessed by repeadidly collecting blood before and after the meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy expenditure (basal metabolic rate, diet-induced thermogenesis | Up to six weeks | Basal metabolic rate measured with indirect calorimetry |
| Substrate utilization (respiratory quotient) | Up to six weeks | Respiratory quotient assessed with indirect calorimetry |
| Body composition | Up to six weeks | Body impedance analysis before meal |
| Satiety | Up to six weeks | Appetite rating with visual analogue scale (VAS) from 0mm-100mm (0mm=not at all and 100mm=extreme) |
| Weight | Up to six weeks | Measurement of weight with a standard scale |
| Motivation to eat | Up to six weeks | Motivation to eat measured with a speed clicking test |
| Systolic and diastolic blood pressure | Up to six weeks | Assessment of blood pressure with a standard blood pressure monitor |
| Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides) | Up to six weeks | Blood collection fasted |
| Perceived stress | Up to six weeks | Measured by perceived stress questionnaire |
| C-peptide | Up to six weeks | Change in blood cortisol assessed by repeadidly collecting blood before and after the meal |
| Insulin | Up to six weeks | Change in blood cortisol assessed by repeadidly collecting blood before and after the meal |
| Blood glucose | Up to six weeks | Change in blood glucose assessed by repeadidly collecting blood before and after the meal |
| Neuroendocrine hormones (thyroid hormones, GLP1, glucagon, ACTH) | Up to six weeks | Change in blood cortisol assessed by repeadidly collecting blood before and/or after the meal |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATOREleonora Seelig, PD Dr. med.
Sponsor and principal investigator
Outcome results
None listed