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NCT Number: NCT07213245

Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF)

The overall aim of this project is to study the effects of short-term high ultra-processed food intake, compared to nutrient- and energy density matched low ultra-processed food (UPF) intake, on energy intake and appetite.

A total of 24 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. A randomized 2*2 factorial four-way crossover study will be conducted at the Department of Internal medicine and Clinical Nutrition at the University of Gothenburg, comparing a high-UPF meal to a low-UPF meal also with high and/or low energy density. A supervised breakfast meal will be served, and postprandial blood samples and appetite measures will be collected continuously up to 4 hours after the breakfast meal. Subsequently, an ad libitum lunch meal will be served, and energy intake will be recorded.

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Key information

Conditions

Appetite Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Obesity-related Medical Conditions Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of internal medicine and clinical nutrition, University olf Gothenburg

Gothenburg, 40530, Sweden

Location status: Recruiting

Location contact

Therese Karlsson, PhD

CONTACT

+46704089150

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) 18.5-30 kg/m2
  • Fasting glucose < 6.1 mmol/l
  • Hb >110 g/L
  • Weight stability the last 3 months +/-5%

Exclusion criteria

  • Food allergies, intolerances or preferences preventing consumption of any products included in the study.
  • Unable to sufficiently understand written and spoken Swedish or English to provide written consent and understand information and instructions from the study personal.
  • Pregnant, lactating or planning a pregnancy during the study period.
  • Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
  • History of gastrointestinal conditions or major gastrointestinal surgery (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.).
  • Type 1 diabetes or type 2 diabetes.
  • Thyroid disorder.
  • Current smoking, vaping.
  • Following any weight reduction program or having followed one during the last 6 months prior to screening.
  • Not habitually eating breakfast (<5 times/week).
  • Restrained eating based on the three-factor eating questionnaire.

Treatment and study plan

Meal high in energy density, high in ultra-processed food

Other

Meal high in energy density, high in ultra-processed food

Meal high in energy density, low in ultra-processed food

Other

Meal high in energy density, low in ultra-processed food

Meal low in energy density, high in ultra-processed food

Other

Meal low in energy density, high in ultra-processed food

Meal low in energy density, low in ultra-processed food

Other

Meal low in energy density, low in ultra-processed food

Primary outcomes

  1. Self-reported appetite

    Time frame: Baseline to 8 hours after test meal

    Appetite ratings (hunger, fullness, and desire to eat) will be assessed using separate 100-mm Visual Analogue Scales (VAS), anchored with "not at all" (0 mm) and "extremely" (100 mm). Higher scores indicate greater perceived intensity.

  2. Energy intake

    Time frame: 4 hours after test meal

    Energy intake estimated by nutrient calculation of leftover food at the ad libitum lunch meal

  3. Gastrointestinal hormones - incretins

    Time frame: Baseline to 4 hours after test meal

    Difference between groups in incretins GIP and GLP-1 in response to meal

  4. Gastrointestinal hormones - cholecystokinin

    Time frame: Baseline to 4 hours after test meal

    Difference between groups in cholecystokinin in response to meal

  5. Gastrointestinal hormones - peptide YY

    Time frame: Baseline to 4 hours after test meal

    Difference between groups in peptide YY (PYY) in response to meal

  6. Gastrointestinal hormones - ghrelin

    Time frame: Baseline to 4 hours after test meal

    Difference between groups in ghrelin in response to meal

Secondary outcomes

  1. Eating rate

    Time frame: Baseline til end of study meal

    Time it takes to eat the study meal until satisfied

  2. Glucose postprandial

    Time frame: Baseline to 4 hours after test meal

    Difference between groups in postprandial glucose in response to meal.

  3. Insulin postprandial

    Time frame: Baseline to 4 hours after test meal

    Difference between groups in postprandial insulin in response to meal.

  4. Lipid metabolism

    Time frame: Baseline to 4 hours after test meal

    Difference between groups in postprandial lipid metabolism in response to meal.

  5. Metabolome

    Time frame: Baseline to 4 hours after test meal

    Differences between groups in metabolome (plasma) measured using metabolomics in response to meals.

  6. Proteome

    Time frame: Baseline to 4 hours after test meal

    Differences between groups in proteome (plasma) measured using proteomics in response to meals.

  7. Self-reported prospective energy intake

    Time frame: From 30 min until midnight or bedtime (which ever comes first)

    Self-reported prospective energy intake during the remainder of the day

  8. Inflammatory markers in blood - cytokines

    Time frame: Baseline to 4 hours after test meal

    Differences between groups in immunological responses (cytokines) in response to meal.

  9. Inflammatory markers in blood - lipopolysaccharides

    Time frame: Baseline to 4 hours after test meal

    Differences between groups in immunological responses (lipopolysaccharides) in response to meal.

  10. Inflammatory markers in blood - GlycA

    Time frame: Baseline to 4 hours after test meal

    Differences between groups in immunological responses (GlycA) in response to meal.

  11. Lipid profile

    Time frame: Baseline to 4 hours after test meal

    Differences between groups in lipid profile (plasma) measured using lipidomics in response to meals.

Other outcomes

  1. Determinants of energy intake - proteome

    Time frame: Baseline

    Correlation between baseline proteome measured using proteomics and the primary outcome energy intake

  2. Determinants of energy intake - metabolome

    Time frame: Baseline

    Correlation between baseline metabolome measured using metabolomics and primary outcome energy intake

  3. Determinants of energy intake - body composition

    Time frame: Baseline

    Correlation between baseline body composition (fat percentage and fat free mass percentage) measured using Bioelectrical impedance analysis (BIA) and primary outcome energy intake

  4. Determinants of energy intake - metabolic markers

    Time frame: Baseline

    Correlation between baseline metabolic markers, fasting plasma glucose, insulin, and triglycerides measured via standard clinical chemistry methods, and primary outcome energy intake

  5. Determinants of energy intake - physical activity

    Time frame: Baseline

    Correlation between baseline self-reported physical activity and primary outcome energy intake

  6. Determinants of energy intake - diet

    Time frame: Baseline

    Correlation between baseline diet (macro- and micronutrient intake, dietary patterns, food group intake) estimated from a 4-day dietary record and primary outcome energy intake

  7. Determinants of energy intake - microbiome

    Time frame: Baseline

    Correlation between baseline gut microbiome composition-assessed using metagenomic shotgun sequencing and 16S rRNA analysis-and the primary outcome of energy intake.

Study contacts

Contact information is provided by the study sponsor or research team.

Linnea Bärebring, PhD

CONTACT

[email protected]

Therese Karlsson, PhD

CONTACT

[email protected]

+46704089150

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF): a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Dec 15, 2025

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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