HealthyNutriEV RCTNCT07381933
The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body
A study testing Cloudberries and Lingonberries in people with Healthy and Extracellular Vesicles, run by University of Oulu at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Extracellular Vesicles
- What is being tested?
- Cloudberries and Lingonberries
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 23 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu, 90029
Nea Hakkarainen, +358 294 48 0000, nea.hakkarainen@student.oulu.fi
Terhi Ruuska-Loewald, MD, PhD, terhi.ruuska-loewald@oulu.fi
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy, Extracellular Vesicles
- Being tested
- Cloudberries, Lingonberries
- Keywords
- extracellular vesicles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CloudberriesDietary supplement
Participants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days.
LingonberriesDietary supplement
Participants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Cloudberry Group | Experimental | 30 participants will be allocated to Cloudberry Group. Receives: Dietary Supplement: Cloudberries |
| Lingonberry Group | Experimental | 30 participants will be allocated to Lingonberry Group. Receives: Dietary Supplement: Lingonberries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (pre-intervention) to Day 7 (post-intervention)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (pre-intervention) to Day 7 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start23 Jan 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized (using block randomization) into two groups. Each group receives a different intervention (cloudberries or lingonberries). Both groups are treated simultaneously (in parallel) The design compares outcomes between these two parallel arms.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- European Innovation Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381933
- Sponsor's protocol ID
- 2025-16589
- Other IDs
- 101161353, 2025
- Acronym
- NutriEV RCT
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared after reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body
- ClinicalTrials.gov ID
- NCT07381933
- Acronym / sponsor ID
- NutriEV RCT / 2025-16589
- Conditions
- Healthy, Extracellular Vesicles
- Keywords
- extracellular vesicles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- European Innovation Council
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized (using block randomization) into two groups. Each group receives a different intervention (cloudberries or lingonberries). Both groups are treated simultaneously (in parallel) The design compares outcomes between these two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Cloudberry Group | Experimental | Dietary Supplement: Cloudberries30 participants will be allocated to Cloudberry Group. |
| Lingonberry Group | Experimental | Dietary Supplement: Lingonberries30 participants will be allocated to Lingonberry Group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CloudberriesParticipants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days. | Dietary supplement | Cloudberry Group |
| LingonberriesParticipants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days | Dietary supplement | Lingonberry Group |
Primary outcome
Impact of Dietary Berries on Extracellular Vesicle Communication and Host Immunity
Time frame: From baseline (pre-intervention) to Day 7 (post-intervention)
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.
6 secondary outcomes
Changes in Plasma Cytokine Profiles Following Dietary Intervention
Time frame: Baseline (pre-intervention) to Day 7 (post-intervention)
Host Response in Blood Following Dietary Intervention
Time frame: Baseline (pre-intervention) to Day 7 (post-intervention)
Detection and quantification of Berry-Derived Extracellular Vesicles in Human Faeces
Time frame: From baseline to Day 7 (post-intervention)
Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Urine
Time frame: From baseline to Day 7 (post-intervention)
Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Sweat
Time frame: From baseline to Day 7 (post-intervention)
Changes in Extracellular Vesicle Size, Concentration, and Cargo after Nutritional Intervention
Time frame: From baseline (pre-intervention) to Day 7 (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- NutriEV project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will be shared after reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cloudberries and Lingonberries in people with Healthy and Extracellular Vesicles, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nea Hakkarainen (+358 294 48 0000, nea.hakkarainen@student.oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Dietary Berries on Extracellular Vesicle Communication and Host Immunity (time frame: From baseline (pre-intervention) to Day 7 (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.