CClinicalTrials.gg
RecruitingNCT07634159UPFrontUpdated Aug 24, 2026

Health Effects of Ultra-processed Food Intake

An interventional study of Diet high in UPF and Diet low in UPF in Cardiometabolic Risk Factors, Microbiota and Diet Interventions, sponsored by Göteborg University. Recruiting at 1 site in Sweden. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Göteborg University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

Ultra-processed food (UPF) intake has been related to negative health effects and increased energy intake in previous intervention studies. Thus, previous studies have seen weight gain from higher UPF intake which obscures the potential 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.

02

Conditions studied

  • Cardiometabolic Risk Factors
  • Microbiota
  • Diet Interventions

Keywords

  • Ultra-processed food
03

In context

Lead sponsor

Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • Habitually eats breakfast, lunch and dinner
  • Has provided informed consent to participate in the study

Exclusion criteria

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
  • >8h/week of intense physical activity
  • 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
  • Deemed likely to have poor adherence
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Sequence 1: high UPF, low UPF

    Diet high in UPF, followed by a diet low in UPF

    Other: Diet high in UPF · Other: Diet low in UPF

  • Experimental
    Sequence 2: low UPF, high UPF

    Diet low in UPF, followed by a diet high in UPF

    Other: Diet high in UPF · Other: Diet low in UPF

Interventions

  • OtherDiet high in UPF

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

  • OtherDiet low in UPF

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

06

What researchers measure

Primary outcomes

  1. Leptin

    Time frame: Change from baseline to 6 weeks

  2. ApoB

    Apolipoprotein B

    Time frame: Change from baseline to 6 weeks

Secondary outcomes

  1. Leptin

    Time frame: Change from baseline to 2 weeks

  2. ApoB

    Apolipoprotein B

    Time frame: Change from baseline to 2 weeks

  3. Ghrelin, PYY, cholecystokinin, insulin

    Other appetite-regulating hormones

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

  4. Blood lipid profile

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

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

  5. Body weight

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

  6. Body composition

    Fat mass and fat-free mass

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

  7. Blood pressure

    Diastolic and systolic blood pressure

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

  8. Biomarkers of ultra-processed food intake

    Measured in blood and urine

    Time frame: At 2 weeks and at 6 weeks

  9. Gut microbiome

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

    Time frame: At 2 weeks and 6 weeks

  10. Glucose

    Glucose, measured by continuous blood glucose monitoring

    Time frame: Continuous during the first 2 weeks

  11. Energy intake

    Ad libitum energy intake at standardized test meal

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

  12. Subjective appetite

    Self-rated appetite before and after a standardized test meal

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

  13. Food cravings and eating behavior

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

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

Other outcomes

  1. Oral microbiome

    Change in oral microbial composition

    Time frame: At 2 weeks and 6 weeks

  2. Compliance

    Compliance assessed by food records

    Time frame: At 2 weeks and 6 weeks

  3. Sleep

    Pittsburgh Sleep Quality Index

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

  4. Well-being

    WHO-5 Wellbeing Index

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

07

Study locations

1 of 1 sites recruiting
  • University of Gothenburg
    Gothenburg, 40530, Sweden
    • Linnea Bärebring, PhD, Associate professor · Contact · linnea.barebring@gu.se · 0317863771
    • Therese Karlsson, PhD, Associate professor · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Ethical approvals and legal issues must be considered and resolved before data of individuals can be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07634159
Lead sponsor
Göteborg University
Collaborators
Chalmers University of Technology, Karolinska Institutet
Responsible party
Sponsor
First posted
Jun 8, 2026
Start date
Jun 25, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 24, 2026

Study contacts

Linnea Bärebring, PhD, Associate professor
Contact
linnea.barebring@gu.se
0317863771 ext. +46
Therese Karlsson, PhD, Associate professor
Contact
therese.karlsson@gu.se
Linnea Bärebring, PhD, Associate professor
principal investigator · Göteborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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