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Идёт набор NCT07381933

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

Без фазы С лечением Healthy Extracellular Vesicles

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cloudberries, Lingonberries.
Кому может быть актуально
Состояния в реестре: Healthy, Extracellular Vesicles. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Финляндия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка Cloudberries
    Participants consume 270 grams (equivalent of 3 dl) of cloudberries orally twice daily for 7 days.
  • Пищевая добавка Lingonberries
    Participants consume 200 grams (equivalent of 3 dl) of lingonberries orally twice daily for 7 days

Первичные конечные точки

  • Impact of Dietary Berries on Extracellular Vesicle Communication and Host Immunity [Срок оценки: From baseline (pre-intervention) to Day 7 (post-intervention)]
Вторичные конечные точки (6)
  • Changes in Plasma Cytokine Profiles Following Dietary Intervention [Срок оценки: Baseline (pre-intervention) to Day 7 (post-intervention)]
  • Host Response in Blood Following Dietary Intervention [Срок оценки: Baseline (pre-intervention) to Day 7 (post-intervention)]
  • Detection and quantification of Berry-Derived Extracellular Vesicles in Human Faeces [Срок оценки: From baseline to Day 7 (post-intervention)]
  • Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Urine [Срок оценки: From baseline to Day 7 (post-intervention)]
  • Detection and Quantification of Berry-Derived Extracellular Vesicles in Human Sweat [Срок оценки: From baseline to Day 7 (post-intervention)]
  • Changes in Extracellular Vesicle Size, Concentration, and Cargo after Nutritional Intervention [Срок оценки: From baseline (pre-intervention) to Day 7 (post-intervention)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Финляндия · 1 центр
  • Oulu University Hospital — Oulu

Идентификаторы

NCT: NCT07381933 · 2025-16589 · 101161353

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗