The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Oulu
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cloudberries
Dietary supplementParticipants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days.
Lingonberries
Dietary supplementParticipants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Cloudberry GroupExperimental treatment 1 intervention
Group B: Lingonberry GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From baseline (pre-intervention) to Day 7 (post-intervention)Secondary outcomes
1
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.
Time frame
Baseline (pre-intervention) to Day 7 (post-intervention)2
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.
Time frame
Baseline (pre-intervention) to Day 7 (post-intervention)3
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.
Time frame
From baseline to Day 7 (post-intervention)4
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.
Time frame
From baseline to Day 7 (post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oulu
Lead sponsor
European Innovation Council
Collaborator
Source ClinicalTrials.gov