How eating cloudberries or lingonberries affects tiny cell particles called extracellular vesicles
The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body
We will test whether eating cloudberries or lingonberries for seven days changes extracellular vesicles in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Oulu Academic / other |
| Locations | 1 site (Oulu) |
| Trial ID | NCT07381933 on ClinicalTrials.gov |
What this trial studies
This randomized pilot will enroll 60 healthy adults who are assigned to eat either 270 g of cloudberries or 200 g of lingonberries daily for seven days. Urine, sweat, fecal and blood samples are collected before and after the intervention to isolate extracellular vesicles and monitor immune status. Isolated EVs will be analyzed by transmission electron microscopy, 16S rRNA sequencing, proteomics, and metabolomics to compare composition and distribution pre- and post-intervention. Participants also complete a dietary questionnaire and report probiotic use.
Who should consider this trial
Good fit: Healthy adults aged 18–50 without diabetes, renal failure, pregnancy, immunodeficiency, recent antibiotic use, immunosuppressive medication, or allergy to cloudberries/lingonberries.
Not a fit: People with diabetes, kidney failure, active immune disorders, recent antibiotic or immunosuppressive use, pregnancy, or known berry allergies are excluded or unlikely to benefit from this short dietary intervention.
Why it matters
Potential benefit: If successful, the results could help link simple dietary choices to changes in cell-to-cell signalling and inform future diagnostics or nutritional recommendations.
How similar studies have performed: Previous animal and dietary studies have shown berries can change gut microbes and metabolites and extracellular vesicle analysis is an emerging method, but direct human evidence linking berry intake to EV signalling is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-50 * Individuals of all heights and weights and both female and male sexes are accepted * Written informed consent is required from all study participants * Use of probiotics is allowed, but the usage will be reported Exclusion Criteria: * Known or suspected allergy to cloudberries or lingonberries * Current dermatological or gastrointestinal conditions requiring treatment or interfering the sampling * Renal failure * Type 1 or type 2 diabetes * Pregnancy * Immunodeficiency or any condition affecting the immune system, e.g. chronic viral infection * Ongoing antibiotic treatment or antibiotic treatment within the past 3 months * Immunosuppressive medication or other medication that can be influenced by the intervention
Where this trial is running
Oulu
- Oulu University Hospital — Oulu, Finland (Recruiting)
Study contacts
- Study coordinator: Nea Hakkarainen
- Email: nea.hakkarainen@student.oulu.fi
- Phone: +358 294 48 0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.