Cardiometabolic Risk Factors, Diet Interventions, Microbiota
Conditions
Keywords
Ultra-processed food
Brief summary
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.
Interventions
OTHERDiet high in UPF
Diet high in Ultra-processed food (\>80 % of total energy intake)
OTHERDiet low in UPF
Diet low in Ultra-processed food (\<20 % of total energy intake)
Sponsors
Göteborg University
Chalmers University of Technology
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Masking description
Those conducting laboratory analyses will be blinded to the allocation of participants.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leptin | Change from baseline to 6 weeks | — |
| ApoB | Change from baseline to 6 weeks | Apolipoprotein B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leptin | Change from baseline to 2 weeks | — |
| ApoB | Change from baseline to 2 weeks | Apolipoprotein B |
| Ghrelin, PYY, cholecystokinin, insulin | Change from baseline to 2 weeks and from baseline to 6 weeks | Other appetite-regulating hormones |
| Blood lipid profile | Change from baseline to 2 weeks and from baseline to 6 weeks | ApoA1, LDL, HDL, VLDL, total cholesterol, triglycerides, Lp(a) |
| Body weight | Change from baseline to 2 weeks and from baseline to 6 weeks | — |
| Body composition | Change from baseline to 2 weeks and from baseline to 6 weeks | Fat mass and fat-free mass |
| Blood pressure | Change from baseline to 2 weeks and from baseline to 6 weeks | Diastolic and systolic blood pressure |
| Biomarkers of ultra-processed food intake | At 2 weeks and at 6 weeks | Measured in blood and urine |
| Gut microbiome | At 2 weeks and 6 weeks | Change in gut microbial composition and diversity (alpha- and beta) |
| Glucose | Continuous during the first 2 weeks | Glucose, measured by continuous blood glucose monitoring |
| Energy intake | Change from baseline to 2 weeks and from baseline to 6 weeks | Ad libitum energy intake at standardized test meal |
| Subjective appetite | Change from baseline to 2 weeks and from baseline to 6 weeks | Self-rated appetite before and after a standardized test meal |
| Food cravings and eating behavior | Change from baseline to 2 weeks and from baseline to 6 weeks | Control of Eating Questionnaire, Three Factor Eating Questionnaire, Power of Food Scale |
Countries
Sweden
Contacts
CONTACTLinnea Bärebring, PhD, Associate professor
CONTACTTherese Karlsson, PhD, Associate professor
PRINCIPAL_INVESTIGATORLinnea Bärebring, PhD, Associate professor
Göteborg University
Outcome results
None listed