Cardiometabolic Risk FactorsUPFrontNCT07634159
Health Effects of Ultra-processed Food Intake
A study testing Diet high in UPF and Diet low in UPF in people with Cardiometabolic Risk Factors and Microbiota, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors, Microbiota, Diet Interventions
- What is being tested?
- Diet high in UPF and Diet low in UPF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jun 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Therese Karlsson, PhD, Associate professor contact
Sweden1 site, 1 recruiting
- Recruiting
University of Gothenburg
Gothenburg, 40530
Linnea Bärebring, PhD, Associate professor, 0317863771 ext. +46, linnea.barebring@gu.se
Therese Karlsson, PhD, Associate professor
About this study
Official title: Health Effects of Ultra-processed Food Intake: a Randomized Crossover Feeding Study
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.
- Conditions
- Cardiometabolic Risk Factors, Microbiota, Diet Interventions
- Being tested
- Diet high in UPF, Diet low in UPF
- Keywords
- Ultra-processed food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet high in UPFOther
Diet high in Ultra-processed food (>80 % of total energy intake)
Diet low in UPFOther
Diet low in Ultra-processed food (<20 % of total energy intake)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: high UPF, low UPF | Experimental | Diet high in UPF, followed by a diet low in UPF Receives: Other: Diet high in UPF; Other: Diet low in UPF |
| Sequence 2: low UPF, high UPF | Experimental | Diet low in UPF, followed by a diet high in UPF Receives: Other: Diet high in UPF; Other: Diet low in UPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptin
Measured: Change from baseline to 6 weeks
ApoB
Apolipoprotein B
Measured: Change from baseline to 6 weeks
Secondary outcomes (13)
Leptin
Measured: Change from baseline to 2 weeks
ApoB
Apolipoprotein B
Measured: Change from baseline to 2 weeks
Ghrelin, PYY, cholecystokinin, insulin
Other appetite-regulating hormones
Measured: Change from baseline to 2 weeks and from baseline to 6 weeks
Blood lipid profile
ApoA1, LDL, HDL, VLDL, total cholesterol, triglycerides, Lp(a)
Measured: Change from baseline to 2 weeks and from baseline to 6 weeks
Body weight
Measured: Change from baseline to 2 weeks and from baseline to 6 weeks
Body composition
Fat mass and fat-free mass
Measured: Change from baseline to 2 weeks and from baseline to 6 weeks
Blood pressure
Diastolic and systolic blood pressure
Measured: Change from baseline to 2 weeks and from baseline to 6 weeks
Biomarkers of ultra-processed food intake
Measured in blood and urine
Measured: At 2 weeks and at 6 weeks
Gut microbiome
Change in gut microbial composition and diversity (alpha- and beta)
Measured: At 2 weeks and 6 weeks
Glucose
Glucose, measured by continuous blood glucose monitoring
Measured: Continuous during the first 2 weeks
Energy intake
Ad libitum energy intake at standardized test meal
Measured: Change from baseline to 2 weeks and from baseline to 6 weeks
Subjective appetite
Self-rated appetite before and after a standardized test meal
Measured: Change from baseline to 2 weeks and from baseline to 6 weeks
Food cravings and eating behavior
Control of Eating Questionnaire, Three Factor Eating Questionnaire, Power of Food Scale
Measured: Change from baseline to 2 weeks and from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start25 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Chalmers University of Technology, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Linnea Bärebring, PhD, Associate professor, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634159
- Sponsor's protocol ID
- 2025-08976-01
- Other IDs
- 2025
- Acronym
- UPFront
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Ethical approvals and legal issues must be considered and resolved before data of individuals can be shared.