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

Göteborg University

Status: Enrolling

Conditions: Obesity and Obesity-related Medical Conditions; Appetite

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07213245

MEST-UPF

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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