Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals
- Conditions
- Food EffectGlucocorticoidsObesity and Overweight
- Registration Number
- NCT06724692
- Lead Sponsor
- Eleonora Seelig
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 20
- Males aged 18 to 40 years
- BMI 18.5-29.9 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Blood cortisol change Up to six weeks Change in blood cortisol assessed by repeadidly collecting blood before and after the meal
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University Hospital Basel
🇨ðŸ‡Basel, Basel-Stadt, Switzerland