The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cloudberries, Lingonberries.
- Who it may be relevant to
- Registry conditions: Healthy, Extracellular Vesicles. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Dietary supplement Cloudberries
Participants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days. - Dietary supplement Lingonberries
Participants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days
Primary outcome measures
- Impact of Dietary Berries on Extracellular Vesicle Communication and Host Immunity [Time frame: From baseline (pre-intervention) to Day 7 (post-intervention)]
Secondary outcome measures (6)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Finland · 1 center
- Oulu University Hospital — Oulu
Identifiers
NCT: NCT07381933 · 2025-16589 · 101161353