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

Switzerland (ICTRP)

ICTRP Studien-ID
NCT06724692 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals (BASEC)

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

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

Untersuchte Krankheit(en)
GlucocorticoidsObesity and OverweightFood Effect (ICTRP)

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

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
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)

nicht verfügbar

Primäre und sekundäre Endpunkte
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)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
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)

Sekundäre IDs
EKNZ 2024-01796 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06724692 (ICTRP)