An interventional study of Cloudberries and Lingonberries in Healthy and Extracellular Vesicles, sponsored by University of Oulu. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University of Oulu · Not applicable, Interventional, and Basic science
This study examines how berry consumption influences the signaling and distribution of extracellular vesicles (EVs) in the human body. EVs are small bilipid-layered nanoparticles released by cells. EVs carry proteins, lipids, and genetic material, and play a key role in cell-to-cell communication. The composition of EVs reflects the state of their cells of origin, and EVs can affect other cells by delivering their biological contents. EVs offer significant potential for both diagnostics and new therapies.
Recent research has shown that EVs can be found in blood, urine, sweat, and can even cross biological barriers such as the blood-brain barrier and placenta. Many living organisms, including mammalian cells, bacteria, and plants, release EVs. Berries such as cloudberries and lingonberries have demonstrated positive effects on gut microbiota and metabolism, supporting digestive and metabolic health.
In this study, a nutritional intervention will be conducted to investigate the effects of berry consumption on extracellular vesicle signaling of human cells and the gut microbiota, as well as the biodistribution of berry-derived vesicles in the human body.
This randomized clinical pilot study will enroll 60 healthy adults. Participants will consume either 270 grams of cloudberries or 200 grams of lingonberries (equivalent of 3 dl) daily, for 7 days.
Urine, sweat and faecal samples will be collected from participants both before and after the nutritional intervention. Researchers will isolate EVs from samples and analyze the isolated EVs using transmission electron microscopy (TEM), 16S RNA sequencing, proteomics, and metabolomics. The results obtained from vesicle analyses before and after the nutritional intervention will be compared. Additionally, blood samples will be collected to monitor the immunological status of participants and also information on participants' dietary habits will be collected through a questionnaire.
University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 participants will be allocated to Cloudberry Group.
Dietary Supplement: Cloudberries
30 participants will be allocated to Lingonberry Group.
Dietary Supplement: Lingonberries
Participants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days.
Participants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days
Impact of Dietary Berries on Extracellular Vesicle Communication and Host Immunity
The investigators will assess the effects of berry consumption on the human body, including alterations in gut microbiota composition and immune cell profiles, with a particular focus on changes in extracellular vesicle (EV) signaling.
Time frame: From baseline (pre-intervention) to Day 7 (post-intervention)
Changes in Plasma Cytokine Profiles Following Dietary Intervention
The investigators will quantify plasma cytokine levels (e.g. IL-6, TNF-α, IL-10) from the participants' blood samples to assess systemic immunological response to the dietary intervention.
Time frame: Baseline (pre-intervention) to Day 7 (post-intervention)
Host Response in Blood Following Dietary Intervention
The investigators will analyse host immunological response to the dietary intervention via blood sample analysis. Peripheral white blood cell subsets (e.g. T cells, B cells and monocytes) will be determined using flow cytometry to evaluate cellular immune response.
Time frame: Baseline (pre-intervention) to Day 7 (post-intervention)
Detection and quantification of Berry-Derived Extracellular Vesicles in Human Faeces
The investigators will detect the presence of the berry-derived EVs in faeces after a dietary intervention.
Time frame: From baseline to Day 7 (post-intervention)
Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Urine
The investigators will detect the presence of the berry-derived EVs outside the intestinal tract in urine after a dietary intervention.
Time frame: From baseline to Day 7 (post-intervention)
Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Sweat
The investigators will detect the presence of the berry-derived EVs outside the intestinal tract in sweat after a dietary intervention.
Time frame: From baseline to Day 7 (post-intervention)
Changes in Extracellular Vesicle Size, Concentration, and Cargo after Nutritional Intervention
The investigators will detect changes in EV properties such as size, concentration, and cargo profile following the dietary intervention, when analysing urine, faecal and sweat samples before and after the dietary intervention.
Time frame: From baseline (pre-intervention) to Day 7 (post-intervention)
Plan to share: No — IPD will be shared after reasonable request
Started Jan 2026 (actual). Primary completion is estimated for Aug 2026, 7 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.