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

Not Applicable
Recruiting
Conditions
Food Effect
Glucocorticoids
Obesity and Overweight
Registration Number
NCT06724692
Lead Sponsor
Eleonora Seelig
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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Male
Target Recruitment
20
Inclusion Criteria
  • Males aged 18 to 40 years
  • BMI 18.5-29.9 kg/m2
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Blood cortisol changeUp to six weeks

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

Secondary Outcome Measures
NameTimeMethod
Energy expenditure (basal metabolic rate, diet-induced thermogenesisUp to six weeks

Basal metabolic rate measured with indirect calorimetry

Substrate utilization (respiratory quotient)Up to six weeks

Respiratory quotient assessed with indirect calorimetry

Body compositionUp to six weeks

Body impedance analysis before meal

SatietyUp to six weeks

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

WeightUp to six weeks

Measurement of weight with a standard scale

Motivation to eatUp to six weeks

Motivation to eat measured with a speed clicking test

Systolic and diastolic blood pressureUp to six weeks

Assessment of blood pressure with a standard blood pressure monitor

Lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides)Up to six weeks

Blood collection fasted

Perceived stressUp to six weeks

Measured by perceived stress questionnaire

C-peptideUp to six weeks

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

InsulinUp to six weeks

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

Blood glucoseUp to six weeks

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

Neuroendocrine hormones (thyroid hormones, GLP1, glucagon, ACTH)Up to six weeks

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

Trial Locations

Locations (1)

University Hospital Basel

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Basel, Basel-Stadt, Switzerland

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