Menu
Recruiting NCT07213245

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

No phase Interventional Appetite Obesity and Obesity-related Medical Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meal high in energy density, high in ultra-processed food, Meal high in energy density, low in ultra-processed food, Meal low in energy density, high in ultra-processed food, Meal low in energy density, low in ultra-processed food.
Who it may be relevant to
Registry conditions: Appetite, Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Self-reported appetite [Time frame: Baseline to 8 hours after test meal]
  • Energy intake [Time frame: 4 hours after test meal]
  • Gastrointestinal hormones - incretins [Time frame: Baseline to 4 hours after test meal]
  • Gastrointestinal hormones - cholecystokinin [Time frame: Baseline to 4 hours after test meal]
  • Gastrointestinal hormones - peptide YY [Time frame: Baseline to 4 hours after test meal]
  • Gastrointestinal hormones - ghrelin [Time frame: Baseline to 4 hours after test meal]
Secondary outcome measures (11)
  • Eating rate [Time frame: Baseline til end of study meal]
  • Glucose postprandial [Time frame: Baseline to 4 hours after test meal]
  • Insulin postprandial [Time frame: Baseline to 4 hours after test meal]
  • Lipid metabolism [Time frame: Baseline to 4 hours after test meal]
  • Metabolome [Time frame: Baseline to 4 hours after test meal]
  • Proteome [Time frame: Baseline to 4 hours after test meal]
  • Self-reported prospective energy intake [Time frame: From 30 min until midnight or bedtime (which ever comes first)]
  • Inflammatory markers in blood - cytokines [Time frame: Baseline to 4 hours after test meal]
  • Inflammatory markers in blood - lipopolysaccharides [Time frame: Baseline to 4 hours after test meal]
  • Inflammatory markers in blood - GlycA [Time frame: Baseline to 4 hours after test meal]
  • Lipid profile [Time frame: Baseline to 4 hours after test meal]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Prevention

Study locations

Sweden · 1 center
  • Department of internal medicine and clinical nutrition, University olf Gothenburg — Gothenburg

Identifiers

NCT: NCT07213245 · MEST-UPF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗