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

NCT07381933 | Recruiting

• 2 other identifiers: 2025-16589101161353
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy; Extracellular Vesicles

Keywords

extracellular vesicles

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (pre-intervention) to Day 7 (post-intervention)

Secondary Outcomes (6)

• Changes in Plasma Cytokine Profiles Following Dietary Intervention

  Baseline (pre-intervention) to Day 7 (post-intervention)

• Host Response in Blood Following Dietary Intervention

  Baseline (pre-intervention) to Day 7 (post-intervention)

• Detection and quantification of Berry-Derived Extracellular Vesicles in Human Faeces

  From baseline to Day 7 (post-intervention)

• Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Urine

  From baseline to Day 7 (post-intervention)

• Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Sweat

  From baseline to Day 7 (post-intervention)

Study Arms (2)

Cloudberry Group

EXPERIMENTAL

30 participants will be allocated to Cloudberry Group.

Dietary Supplement: Cloudberries

Lingonberry Group

EXPERIMENTAL

30 participants will be allocated to Lingonberry Group.

Dietary Supplement: Lingonberries

Interventions

Cloudberries DIETARY_SUPPLEMENT

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

Cloudberry Group

Lingonberries DIETARY_SUPPLEMENT

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

Lingonberry Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• European Innovation Council: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, 90029, Finland

RECRUITING

Related Links

• NutriEV project website

Central Study Contacts

Nea Hakkarainen

CONTACT

+358 294 48 0000; nea.hakkarainen@student.oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: February 2, 2026
• Study Start: January 23, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)