The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body (NutriEV RCT)

February 5, 2026 updated by: University of Oulu

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cloudberry Group
30 participants will be allocated to Cloudberry Group.
Dietary supplement: Cloudberries
Participants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days.
Experimental: Lingonberry Group
30 participants will be allocated to Lingonberry Group.
Dietary supplement: Lingonberries
Participants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (pre-intervention) to Day 7 (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Plasma Cytokine Profiles Following Dietary Intervention
Time Frame: Baseline (pre-intervention) to Day 7 (post-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.
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)
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.
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)
The investigators will detect the presence of the berry-derived EVs in faeces after a dietary intervention.
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)
The investigators will detect the presence of the berry-derived EVs outside the intestinal tract in urine after a dietary intervention.
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)
The investigators will detect the presence of the berry-derived EVs outside the intestinal tract in sweat after a dietary intervention.
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)
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.
From baseline (pre-intervention) to Day 7 (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

European Innovation Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-16589
  • 101161353 (Other Grant/Funding Number: European Innovation Council (EIC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be shared after reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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