Health Effects of Ultra-processed Food Intake (UPFront)
21. august 2026 oppdatert av: Göteborg University
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Linnea Bärebring, PhD, Associate professor
- Telefonnummer: +46 0317863771
- E-post: linnea.barebring@gu.se
Studer Kontakt Backup
- Navn: Therese Karlsson, PhD, Associate professor
- E-post: therese.karlsson@gu.se
Studiesteder
-
-
-
Gothenburg, Sverige, 40530
- Rekruttering
- University of Gothenburg
-
Ta kontakt med:
- Linnea Bärebring, PhD, Associate professor
- Telefonnummer: +46 0317863771
- E-post: linnea.barebring@gu.se
-
Ta kontakt med:
- Therese Karlsson, PhD, Associate professor
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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:
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Sequence 1: high UPF, low UPF
Diet high in UPF, followed by a diet low in UPF
|
Diet high in Ultra-processed food (>80 % of total energy intake)
Diet low in Ultra-processed food (<20 % of total energy intake)
|
|
Eksperimentell: Sequence 2: low UPF, high UPF
Diet low in UPF, followed by a diet high in UPF
|
Diet high in Ultra-processed food (>80 % of total energy intake)
Diet low in Ultra-processed food (<20 % of total energy intake)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Leptin
Tidsramme: Change from baseline to 6 weeks
|
Change from baseline to 6 weeks
|
|
|
ApoB
Tidsramme: Change from baseline to 6 weeks
|
Apolipoprotein B
|
Change from baseline to 6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Leptin
Tidsramme: Change from baseline to 2 weeks
|
Change from baseline to 2 weeks
|
|
|
ApoB
Tidsramme: Change from baseline to 2 weeks
|
Apolipoprotein B
|
Change from baseline to 2 weeks
|
|
Ghrelin, PYY, cholecystokinin, insulin
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
Other appetite-regulating hormones
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Blood lipid profile
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
ApoA1, LDL, HDL, VLDL, total cholesterol, triglycerides, Lp(a)
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Body weight
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
|
Body composition
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
Fat mass and fat-free mass
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Blood pressure
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
Diastolic and systolic blood pressure
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Biomarkers of ultra-processed food intake
Tidsramme: At 2 weeks and at 6 weeks
|
Measured in blood and urine
|
At 2 weeks and at 6 weeks
|
|
Gut microbiome
Tidsramme: At 2 weeks and 6 weeks
|
Change in gut microbial composition and diversity (alpha- and beta)
|
At 2 weeks and 6 weeks
|
|
Glucose
Tidsramme: Continuous during the first 2 weeks
|
Glucose, measured by continuous blood glucose monitoring
|
Continuous during the first 2 weeks
|
|
Energy intake
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
Ad libitum energy intake at standardized test meal
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Food cravings and eating behavior
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
Control of Eating Questionnaire, Three Factor Eating Questionnaire, Power of Food Scale
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Subjective appetite
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
Self-rated appetite before and after a standardized test meal
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Oral microbiome
Tidsramme: At 2 weeks and 6 weeks
|
Change in oral microbial composition
|
At 2 weeks and 6 weeks
|
|
Compliance
Tidsramme: At 2 weeks and 6 weeks
|
Compliance assessed by food records
|
At 2 weeks and 6 weeks
|
|
Sleep
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
Pittsburgh Sleep Quality Index
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
|
Well-being
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
|
WHO-5 Wellbeing Index
|
Change from baseline to 2 weeks and from baseline to 6 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Linnea Bärebring, PhD, Associate professor, Göteborg University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. juni 2026
Primær fullføring (Antatt)
1. desember 2027
Studiet fullført (Antatt)
1. desember 2027
Datoer for studieregistrering
Først innsendt
3. juni 2026
Først innsendt som oppfylte QC-kriteriene
3. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. august 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2025-08976-01
- 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
Plan for individuelle deltakerdata (IPD)
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UBESLUTTE
IPD-planbeskrivelse
Ethical approvals and legal issues must be considered and resolved before data of individuals can be shared.
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