Health Effects of Ultra-processed Food Intake (UPFront)
21 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Linnea Bärebring, PhD, Associate professor
- Telefonnummer: +46 0317863771
- E-post: linnea.barebring@gu.se
Studera Kontakt Backup
- Namn: Therese Karlsson, PhD, Associate professor
- E-post: therese.karlsson@gu.se
Studieorter
-
-
-
Gothenburg, Sverige, 40530
- Rekrytering
- University of Gothenburg
-
Kontakt:
- Linnea Bärebring, PhD, Associate professor
- Telefonnummer: +46 0317863771
- E-post: linnea.barebring@gu.se
-
Kontakt:
- Therese Karlsson, PhD, Associate professor
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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)
|
|
Experimentell: 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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Leptin
Tidsram: Change from baseline to 6 weeks
|
Change from baseline to 6 weeks
|
|
|
ApoB
Tidsram: Change from baseline to 6 weeks
|
Apolipoprotein B
|
Change from baseline to 6 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Leptin
Tidsram: Change from baseline to 2 weeks
|
Change from baseline to 2 weeks
|
|
|
ApoB
Tidsram: Change from baseline to 2 weeks
|
Apolipoprotein B
|
Change from baseline to 2 weeks
|
|
Ghrelin, PYY, cholecystokinin, insulin
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At 2 weeks and at 6 weeks
|
Measured in blood and urine
|
At 2 weeks and at 6 weeks
|
|
Gut microbiome
Tidsram: At 2 weeks and 6 weeks
|
Change in gut microbial composition and diversity (alpha- and beta)
|
At 2 weeks and 6 weeks
|
|
Glucose
Tidsram: Continuous during the first 2 weeks
|
Glucose, measured by continuous blood glucose monitoring
|
Continuous during the first 2 weeks
|
|
Energy intake
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oral microbiome
Tidsram: At 2 weeks and 6 weeks
|
Change in oral microbial composition
|
At 2 weeks and 6 weeks
|
|
Compliance
Tidsram: At 2 weeks and 6 weeks
|
Compliance assessed by food records
|
At 2 weeks and 6 weeks
|
|
Sleep
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Linnea Bärebring, PhD, Associate professor, Göteborg University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
25 juni 2026
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
1 december 2027
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2025-08976-01
- 2025 (U.S.S. NIH-anslag/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
Plan för individuella deltagardata (IPD)
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OBESLUTSAM
IPD-planbeskrivning
Ethical approvals and legal issues must be considered and resolved before data of individuals can be shared.
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