The influence of differently processed meals on stress hormones in healthy participants

Switzerland (ICTRP)

Identifiant de l'essai ICTRP
NCT06724692 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals (BASEC)

Titre académique
Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals (ICTRP)

Titre public
Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals (ICTRP)

Maladie en cours d'investigation
GlucocorticoidsObesity and OverweightFood Effect (ICTRP)

Intervention étudiée
Other: Ultra-processed breakfastOther: Low-processed breakfast (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
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 (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Blood cortisol change (ICTRP)

Energy expenditure (basal metabolic rate, diet-induced thermogenesis;Substrate utilization (respiratory quotient);Body composition;Satiety;Weight;Motivation to eat;Systolic and diastolic blood pressure;Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides);Perceived stress;C-peptide;Insulin;Blood glucose;Neuroendocrine hormones (thyroid hormones, GLP1, glucagon, ACTH) (ICTRP)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
Eleonora Seelig, PD Dr. med.;Eleonora Seelig, PD Dr. med.;Eleonora Seelig, PD Dr. med., eleonora.seelig@usb.ch, 0041 61 328 63 23;0041 61 328 63 23, Sponsor and principal investigator, (ICTRP)

ID secondaires
EKNZ 2024-01796 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06724692 (ICTRP)