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Not yet recruiting NCT07634159

Health Effects of Ultra-processed Food Intake

No phase Interventional Cardiometabolic Risk Factors Microbiota Diet Interventions

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: Diet high in UPF, Diet low in UPF.
Who it may be relevant to
Registry conditions: Cardiometabolic Risk Factors, Microbiota, Diet Interventions. Basic parameters: 20 years — 60 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 →

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Official title

Health Effects of Ultra-processed Food Intake: a Randomized Crossover Feeding Study

Overview

Ultra-processed food (UPF) intake has been related to negative health effects and incresed energy intake in previous intervention studies. Thus, previous studies have seen weight gain from higher UPF intake which obscures the potentital to see effects on cardiometabolic biomarkers, independent of weight changes. The overall aim of this project is to study the causal effects of a high UPF diet, compared to a nutrient-matched low UPF diet, on appetite and cardiometabolic health in a weight-stable context.

Interventions

  • Other Diet high in UPF
    Diet high in Ultra-processed food (\>80 % of total energy intake)
  • Other Diet low in UPF
    Diet low in Ultra-processed food (\<20 % of total energy intake)

Primary outcome measures

  • Leptin [Time frame: Change from baseline to 6 weeks]
  • ApoB [Time frame: Change from baseline to 6 weeks]
Secondary outcome measures (12)
  • Leptin [Time frame: Change from baseline to 2 weeks]
  • ApoB [Time frame: Change from baseline to 2 weeks]
  • Ghrelin, PYY, cholecystokinin, insulin [Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks]
  • Blood lipid profile [Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks]
  • Body weight [Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks]
  • Body composition [Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks]
  • Blood pressure [Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks]
  • Biomarkers of ultra-processed food intake [Time frame: At 2 weeks and at 6 weeks]
  • Gut microbiome [Time frame: At 2 weeks and 6 weeks]
  • Glucose [Time frame: Continuous during the first 2 weeks]
  • Energy intake [Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks]
  • Subjective appetite [Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks]

Eligibility criteria

Inclusion criteria

  • Age 20-60 years
  • Weight stable (less than 5% weight change in the past 3 months)
  • No plans to change weight
  • Willing to eat the study diet and a mixed diet
  • Has provided informed consent to participate in the study

Exclusion criteria

  • Allergy or intolerance to foods included in the study. Participants with lactose intolerance treated with lactase may participate if they take enzymes.
  • BMI <18.5 or >35 kg/m²
  • Use of medications known to significantly affect appetite (e.g., oral corticosteroids, antipsychotic medications, or GLP-1 receptor agonists)
  • Use of lipid-lowering medications (e.g., statins or PCSK9 inhibitors)
  • Diagnosed diabetes or capillary blood glucose at or above 12.2 mmol/L
  • Disease associated with malabsorption (e.g., inflammatory bowel disease or celiac disease)
  • Previous bariatric surgery
  • Established cardiovascular disease (heart failure, myocardial infarction, or stroke) or cancer
  • Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during the study

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
Open label
Primary purpose
Prevention

Study locations

Sweden · 1 center
  • University of Gothenburg — Gothenburg

Identifiers

NCT: NCT07634159 · 2025-08976-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗