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Completed

NCT Number: NCT06724692

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultra-processed breakfast

Other

With this intervention, participants will consume ultra-processed foods

Low-processed breakfast

Other

With this intervention, participants will consume low-processed foods

Primary outcomes

  1. Blood cortisol change

    Time frame: Up to six weeks

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

Secondary outcomes

  1. Energy expenditure (basal metabolic rate, diet-induced thermogenesis

    Time frame: Up to six weeks

    Basal metabolic rate measured with indirect calorimetry

  2. Substrate utilization (respiratory quotient)

    Time frame: Up to six weeks

    Respiratory quotient assessed with indirect calorimetry

  3. Body composition

    Time frame: Up to six weeks

    Body impedance analysis before meal

  4. Satiety

    Time frame: Up to six weeks

    Appetite rating with visual analogue scale (VAS) from 0mm-100mm (0mm=not at all and 100mm=extreme)

  5. Weight

    Time frame: Up to six weeks

    Measurement of weight with a standard scale

  6. Motivation to eat

    Time frame: Up to six weeks

    Motivation to eat measured with a speed clicking test

  7. Systolic and diastolic blood pressure

    Time frame: Up to six weeks

    Assessment of blood pressure with a standard blood pressure monitor

  8. Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides)

    Time frame: Up to six weeks

    Blood collection fasted

  9. Perceived stress

    Time frame: Up to six weeks

    Measured by perceived stress questionnaire

  10. C-peptide

    Time frame: Up to six weeks

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

  11. Insulin

    Time frame: Up to six weeks

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

  12. Blood glucose

    Time frame: Up to six weeks

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

  13. Neuroendocrine hormones (thyroid hormones, GLP1, glucagon, ACTH)

    Time frame: Up to six weeks

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

Sponsors and collaborators

Lead sponsor

Eleonora Seelig

Other

Registry information

Acronym: UltraCort

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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