NCT07634159

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Cardiometabolic Risk FactorsMicrobiotaDiet Interventions

Keywords

Ultra-processed food

Outcome Measures

Primary Outcomes (2)

  • Leptin

    Change from baseline to 6 weeks

  • ApoB

    Apolipoprotein B

    Change from baseline to 6 weeks

Secondary Outcomes (13)

  • Leptin

    Change from baseline to 2 weeks

  • ApoB

    Change from baseline to 2 weeks

  • Ghrelin, PYY, cholecystokinin, insulin

    Change from baseline to 2 weeks and from baseline to 6 weeks

  • Blood lipid profile

    Change from baseline to 2 weeks and from baseline to 6 weeks

  • Body weight

    Change from baseline to 2 weeks and from baseline to 6 weeks

  • +8 more secondary outcomes

Other Outcomes (4)

  • Oral microbiome

    At 2 weeks and 6 weeks

  • Compliance

    At 2 weeks and 6 weeks

  • Sleep

    Change from baseline to 2 weeks and from baseline to 6 weeks

  • +1 more other outcomes

Study Arms (2)

Sequence 1: high UPF, low UPF

EXPERIMENTAL

Diet high in UPF, followed by a diet low in UPF

Other: Diet high in UPFOther: Diet low in UPF

Sequence 2: low UPF, high UPF

EXPERIMENTAL

Diet low in UPF, followed by a diet high in UPF

Other: Diet high in UPFOther: Diet low in UPF

Interventions

Diet high in UPFOTHER

Diet high in Ultra-processed food (\>80 % of total energy intake)

Sequence 1: high UPF, low UPFSequence 2: low UPF, high UPF
Diet low in UPFOTHER

Diet low in Ultra-processed food (\<20 % of total energy intake)

Sequence 1: high UPF, low UPFSequence 2: low UPF, high UPF

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, 40530, Sweden

Location

Study Officials

  • Linnea Bärebring, PhD, Associate professor

    Göteborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linnea Bärebring, PhD, Associate professor

CONTACT

0317863771linnea.barebring@gu.se

Therese Karlsson, PhD, Associate professor

CONTACT

therese.karlsson@gu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Those conducting laboratory analyses will be blinded to the allocation of participants.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 8, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations

SE(1)