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

NCT07213245 | Recruiting

• 1 other identifier: MEST-UPF
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity and Obesity-related Medical Conditions; Appetite

Outcome Measures

Primary Outcomes (6)

• Self-reported appetite

  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.

  Baseline to 8 hours after test meal

• Energy intake

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

  4 hours after test meal

• Gastrointestinal hormones - incretins

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

  Baseline to 4 hours after test meal

• Gastrointestinal hormones - cholecystokinin

  Difference between groups in cholecystokinin in response to meal

  Baseline to 4 hours after test meal

• Gastrointestinal hormones - peptide YY

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

  Baseline to 4 hours after test meal

• Gastrointestinal hormones - ghrelin

  Difference between groups in ghrelin in response to meal

  Baseline to 4 hours after test meal

Secondary Outcomes (11)

• Eating rate

  Baseline til end of study meal

• Glucose postprandial

  Baseline to 4 hours after test meal

• Insulin postprandial

  Baseline to 4 hours after test meal

• Lipid metabolism

  Baseline to 4 hours after test meal

• Metabolome

  Baseline to 4 hours after test meal

Other Outcomes (7)

• Determinants of energy intake - proteome

  Baseline

• Determinants of energy intake - metabolome

  Baseline

• Determinants of energy intake - body composition

  Baseline

Study Arms (4)

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

EXPERIMENTAL

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

EXPERIMENTAL

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

EXPERIMENTAL

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

EXPERIMENTAL

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

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

Interventions

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, 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 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, 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

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Department of internal medicine and clinical nutrition, University olf Gothenburg

Gothenburg, 40530, Sweden

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Food, Processed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Therese Karlsson, PhD

  University of Gothenburg, Institute of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Therese Karlsson, PhD

CONTACT

+46704089150; therese.karlsson@gu.se

Linnea Bärebring, PhD

CONTACT

linnea.barebring@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Factorial assignment 2X2 factorial

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 8, 2025
• Study Start: December 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-11

Locations

SE (1)