Health Effects of Ultra-processed Food Intake
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorGöteborg University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Diet high in UPF
Other interventionDiet high in Ultra-processed food (\>80 % of total energy intake)
Diet low in UPF
Other interventionDiet low in Ultra-processed food (\<20 % of total energy intake)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Sequence 1: high UPF, low UPFExperimental treatment 2 interventions
Group B: Sequence 2: low UPF, high UPFExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Leptin
Time frame
Change from baseline to 6 weeks2
ApoB
Apolipoprotein B
Time frame
Change from baseline to 6 weeksSecondary outcomes
1
Leptin
Time frame
Change from baseline to 2 weeks2
ApoB
Apolipoprotein B
Time frame
Change from baseline to 2 weeks3
Ghrelin, PYY, cholecystokinin, insulin
Other appetite-regulating hormones
Time frame
Change from baseline to 2 weeks and from baseline to 6 weeks4
Blood lipid profile
ApoA1, LDL, HDL, VLDL, total cholesterol, triglycerides, Lp(a)
Time frame
Change from baseline to 2 weeks and from baseline to 6 weeksOther outcomes
1
Oral microbiome
Change in oral microbial composition
Time frame
At 2 weeks and 6 weeks2
Compliance
Compliance assessed by food records
Time frame
At 2 weeks and 6 weeks3
Sleep
Pittsburgh Sleep Quality Index
Time frame
Change from baseline to 2 weeks and from baseline to 6 weeks4
Well-being
WHO-5 Wellbeing Index
Time frame
Change from baseline to 2 weeks and from baseline to 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Göteborg University
Lead sponsor
Chalmers University of Technology
Collaborator
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov