Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-processed breakfast | Active Comparator | During one study phase, subjects receive an ultra-processed breakfast |
|
| Low-processed breakfast | Active Comparator | During the other study phase, subjects receive a low-processed breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-processed breakfast | Other | With this intervention, participants will consume ultra-processed foods |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood cortisol change | Change in blood cortisol assessed by repeadidly collecting blood before and after the meal | Up to six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Energy expenditure (basal metabolic rate, diet-induced thermogenesis | Basal metabolic rate measured with indirect calorimetry | Up to six weeks |
| Substrate utilization (respiratory quotient) | Respiratory quotient assessed with indirect calorimetry |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Since hormone fluctuations associated with the menstrual cycle may alter cortisol levels, women will not be included in the study. Although diversity will be reduced and the statements of the study cannot be applied to the female sex, these strict inclusion criteria allow an optimal homogeneity and increase statistical power.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eleonora Seelig, PD Dr. med. | Sponsor and principal investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Randomized, monocentric, cross-over, open-label study
Not provided
Not provided
Not provided
Not provided
| Low-processed breakfast | Other | With this intervention, participants will consume low-processed foods |
|
| Up to six weeks |
| Body composition | Body impedance analysis before meal | Up to six weeks |
| Satiety | Appetite rating with visual analogue scale (VAS) from 0mm-100mm (0mm=not at all and 100mm=extreme) | Up to six weeks |
| Weight | Measurement of weight with a standard scale | Up to six weeks |
| Motivation to eat | Motivation to eat measured with a speed clicking test | Up to six weeks |
| Systolic and diastolic blood pressure | Assessment of blood pressure with a standard blood pressure monitor | Up to six weeks |
| Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides) | Blood collection fasted | Up to six weeks |
| Perceived stress | Measured by perceived stress questionnaire | Up to six weeks |
| C-peptide | Change in blood cortisol assessed by repeadidly collecting blood before and after the meal | Up to six weeks |
| Insulin | Change in blood cortisol assessed by repeadidly collecting blood before and after the meal | Up to six weeks |
| Blood glucose | Change in blood glucose assessed by repeadidly collecting blood before and after the meal | 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 | Up to six weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |