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| ID | Type | Description | Link |
|---|---|---|---|
| 101161353 | Other Grant/Funding Number | European Innovation Council (EIC) |
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| Name | Class |
|---|---|
| European Innovation Council | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cloudberry Group | Experimental | 30 participants will be allocated to Cloudberry Group. |
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| Lingonberry Group | Experimental | 30 participants will be allocated to Lingonberry Group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cloudberries | Dietary Supplement | Participants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-intervention) to Day 7 (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nea Hakkarainen | Contact | +358 294 48 0000 | nea.hakkarainen@student.oulu.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
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| Oulu University Hospital | Recruiting | Oulu | 90029 | Finland |
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| Label | URL |
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| NutriEV project website | View source |
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IPD will be shared after reasonable request
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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.
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| Lingonberries | Dietary Supplement | Participants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days |
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| 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. |
| Baseline (pre-intervention) to Day 7 (post-intervention) |
| 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. | From baseline to Day 7 (post-intervention) |
| 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. | From baseline to Day 7 (post-intervention) |
| Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Sweat | 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 | 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) |