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

ConditionsAppetite Obesity and Obesity-related Medical Conditions

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-50

SponsorGöteborg University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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%

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

24 Participants

are divided into 4 treatment groups

Group A: Meal high in energy density, high in ultra-processed foodExperimental treatment 1 intervention

Group B: Meal high in energy density, low in ultra-processed foodExperimental treatment 1 intervention

Group C: Meal low in energy density, high in ultra-processed foodExperimental treatment 1 intervention

Group D: Meal low in energy density, low in ultra-processed foodExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to 8 hours after test meal

Energy intake

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

Time frame

4 hours after test meal

Gastrointestinal hormones - incretins

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

Time frame

Baseline to 4 hours after test meal

Gastrointestinal hormones - cholecystokinin

Difference between groups in cholecystokinin in response to meal

Time frame

Baseline to 4 hours after test meal

Secondary outcomes

Eating rate

Time it takes to eat the study meal until satisfied

Time frame

Baseline til end of study meal

Glucose postprandial

Difference between groups in postprandial glucose in response to meal.

Time frame

Baseline to 4 hours after test meal

Insulin postprandial

Difference between groups in postprandial insulin in response to meal.

Time frame

Baseline to 4 hours after test meal

Lipid metabolism

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

Time frame

Baseline to 4 hours after test meal

Other outcomes

Determinants of energy intake - proteome

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

Time frame

Baseline

Determinants of energy intake - metabolome

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

Time frame

Baseline

Determinants of energy intake - body composition

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

Time frame

Baseline

Determinants of energy intake - metabolic markers

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

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Göteborg University

Lead sponsor

Source ClinicalTrials.gov

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