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NCT Number: NCT07381933

The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body

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.

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Key information

Conditions

Healthy Extracellular Vesicles

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90029, Finland

Location status: Recruiting

Location contact

Nea Hakkarainen

CONTACT

[email protected]

+358 294 48 0000

Terhi Ruuska-Loewald, MD, PhD

CONTACT

[email protected]

Terhi Ruuska-Loewald, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cloudberries

Dietary Supplement

Participants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days.

Lingonberries

Dietary Supplement

Participants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nea Hakkarainen

CONTACT

[email protected]

+358 294 48 0000

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • European Innovation Council

Registry information

Acronym: NutriEV RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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