The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body (NutriEV RCT)

University of Oulu

Status: Enrolling

Conditions: Healthy; Extracellular Vesicles

Treatments: Dietary Supplement: Lingonberries; Dietary Supplement: Cloudberries

Study type: Interventional

Funder types: Other

Identifiers

NCT07381933

2025-16589

101161353 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cloudberry Group

Experimental group

Description:

30 participants will be allocated to Cloudberry Group.

Treatment:

Dietary Supplement: Cloudberries

Lingonberry Group

Experimental group

Description:

30 participants will be allocated to Lingonberry Group.

Treatment:

Dietary Supplement: Lingonberries