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NCT Number: NCT07634159

Health Effects of Ultra-processed Food Intake

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.

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Key information

Conditions

Cardiometabolic Risk Factors Diet Interventions Microbiota

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Gothenburg

Gothenburg, 40530, Sweden

Location contact

Linnea Bärebring, PhD, Associate professor

CONTACT

[email protected]

0317863771 ext. +46

Therese Karlsson, PhD, Associate professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet high in UPF

Other

Diet high in Ultra-processed food (>80 % of total energy intake)

Diet low in UPF

Other

Diet low in Ultra-processed food (<20 % of total energy intake)

Primary outcomes

  1. Leptin

    Time frame: Change from baseline to 6 weeks

  2. ApoB

    Time frame: Change from baseline to 6 weeks

    Apolipoprotein B

Secondary outcomes

  1. Leptin

    Time frame: Change from baseline to 2 weeks

  2. ApoB

    Time frame: Change from baseline to 2 weeks

    Apolipoprotein B

  3. Ghrelin, PYY, cholecystokinin, insulin

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    Other appetite-regulating hormones

  4. Blood lipid profile

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    ApoA1, LDL, HDL, VLDL, total cholesterol, triglycerides, Lp(a)

  5. Body weight

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

  6. Body composition

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    Fat mass and fat-free mass

  7. Blood pressure

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    Diastolic and systolic blood pressure

  8. Biomarkers of ultra-processed food intake

    Time frame: At 2 weeks and at 6 weeks

    Measured in blood and urine

  9. Gut microbiome

    Time frame: At 2 weeks and 6 weeks

    Change in gut microbial composition and diversity (alpha- and beta)

  10. Glucose

    Time frame: Continuous during the first 2 weeks

    Glucose, measured by continuous blood glucose monitoring

  11. Energy intake

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    Ad libitum energy intake at standardized test meal

  12. Subjective appetite

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    Self-rated appetite before and after a standasized test meal

  13. Food cravings and eating behavior

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    Control of Eating Questionnaire, Three Factor Eating Questionnaire, Power of Food Scale

Other outcomes

  1. Oral microbiome

    Time frame: At 2 weeks and 6 weeks

    Change in oral microbial composition

  2. Compliance

    Time frame: At 2 weeks and 6 weeks

    Compliance assessed by food records

  3. Sleep

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    Pittsburgh Sleep Quality Index

  4. Well-being

    Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks

    WHO-5 Wellbeing Index

Study contacts

Contact information is provided by the study sponsor or research team.

Linnea Bärebring, PhD, Associate professor

CONTACT

[email protected]

0317863771 ext. +46

Therese Karlsson, PhD, Associate professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Chalmers University of Technology
  • Karolinska Institutet

Registry information

Official study title

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

Acronym: UPFront

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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