Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals

NCT06724692 | Completed DMC

• 1 other identifier: EKNZ 2024-01796
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucocorticoids; Obesity and Overweight; Food Effect

Outcome Measures

Primary Outcomes (1)

• Blood cortisol change

  Change in blood cortisol assessed by repeadidly collecting blood before and after the meal

  Up to six weeks

Secondary Outcomes (13)

• Energy expenditure (basal metabolic rate, diet-induced thermogenesis

  Up to six weeks

• Substrate utilization (respiratory quotient)

  Up to six weeks

• Body composition

  Up to six weeks

• Satiety

  Up to six weeks

• Weight

  Up to six weeks

Study Arms (2)

Ultra-processed breakfast

ACTIVE COMPARATOR

During one study phase, subjects receive an ultra-processed breakfast

Other: Ultra-processed breakfast

Low-processed breakfast

ACTIVE COMPARATOR

During the other study phase, subjects receive a low-processed breakfast

Other: Low-processed breakfast

Interventions

Ultra-processed breakfast OTHER

With this intervention, participants will consume ultra-processed foods

Ultra-processed breakfast

Low-processed breakfast OTHER

With this intervention, participants will consume low-processed foods

Low-processed breakfast

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males aged 18 to 40 years
• BMI 18.5-29.9 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleonora Seelig: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eleonora Seelig, PD Dr. med.

  Sponsor and principal investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, monocentric, cross-over, open-label study

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: December 9, 2024
• Study Start: October 30, 2024
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: March 3, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)