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Health Effects of Ultra-processed Food Intake (UPFront)

3. juni 2026 opdateret af: 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 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Linnea Bärebring, PhD, Associate professor
  • Telefonnummer: +46 0317863771
  • E-mail: linnea.barebring@gu.se

Undersøgelse Kontakt Backup

Studiesteder

  • Sverige
      • Gothenburg, Sverige, 40530
        • University of Gothenburg
        • Kontakt:
        • Kontakt:
          • Therese Karlsson, PhD, Associate professor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde 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
  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence 1: high UPF, low UPF
Diet high in UPF, followed by a diet low in UPF
Andet: Diet high in UPF
Diet high in Ultra-processed food (>80 % of total energy intake)
Andet: Diet low in UPF
Diet low in Ultra-processed food (<20 % of total energy intake)
Eksperimentel: Sequence 2: low UPF, high UPF
Diet low in UPF, followed by a diet high in UPF
Andet: Diet high in UPF
Diet high in Ultra-processed food (>80 % of total energy intake)
Andet: Diet low in UPF
Diet low in Ultra-processed food (<20 % of total energy intake)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Subjective appetite
Tidsramme: Change from baseline to 2 weeks and from baseline to 6 weeks
Self-rated appetite before and after a standasized 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Göteborg University

Samarbejdspartnere

Karolinska Institutet
Chalmers University of Technology

Efterforskere

  • Ledende efterforsker: Linnea Bärebring, PhD, Associate professor, Göteborg University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2025-08976-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Ethical approvals and legal issues must be considered and resolved before data of individuals can be shared.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Diet high in UPF

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