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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Ultra-processed Food Intake: a Randomized Crossover Feeding Study
- ClinicalTrials.gov ID
- NCT07634159
- Acronym / sponsor ID
- UPFront / 2025-08976-01
- Conditions
- Cardiometabolic Risk Factors, Microbiota, Diet Interventions
- Keywords
- Ultra-processed food
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Chalmers University of Technology, Karolinska Institutet
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: high UPF, low UPF | Experimental | Other: Diet high in UPF, Other: Diet low in UPFDiet high in UPF, followed by a diet low in UPF |
| Sequence 2: low UPF, high UPF | Experimental | Other: Diet high in UPF, Other: Diet low in UPFDiet low in UPF, followed by a diet high in UPF |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet high in UPFDiet high in Ultra-processed food (>80 % of total energy intake) | Other | Sequence 1: high UPF, low UPF, Sequence 2: low UPF, high UPF |
| Diet low in UPFDiet low in Ultra-processed food (<20 % of total energy intake) | Other | Sequence 1: high UPF, low UPF, Sequence 2: low UPF, high UPF |
Primary outcome
Leptin
Time frame: Change from baseline to 6 weeks
ApoB
Time frame: Change from baseline to 6 weeks
Apolipoprotein B
13 secondary outcomes
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
Food cravings and eating behavior
Time frame: Change from baseline to 2 weeks and from baseline to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided. Ethical approvals and legal issues must be considered and resolved before data of individuals can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Therese Karlsson, PhD, Associate professor contact
Linnea Bärebring, PhD, Associate professor principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linnea Bärebring, PhD, Associate professor (0317863771 ext. +46, linnea.barebring@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptin (time frame: Change from baseline to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.