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Идёт набор NCT03983603

Plant Stanol Esters and Preventing Asthma Symptoms

Без фазы С лечением Asthma, Allergic Cardiovascular Diseases

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: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters), Placebo soft chew.
Кому может быть актуально
Состояния в реестре: Asthma, Allergic, Cardiovascular Diseases. Базовые параметры: 18 лет — 70 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
Нидерланды
Следующий шаг
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Официальное название

The Effects of Long-term Daily Plant Stanol Ester Intake on Clinical Symptoms in Individuals With Allergic Asthma: an Exploratory Double-blind Randomized Controlled Trial

Обзор

Plant stanols are known to lower low-density lipoprotein cholesterol. However, studies have suggested that these compounds also influence the immune system. Asthmatic responses are predominantly T helper (Th)2 cell dependent, while plant stanols were previously found to activate Th1 cells and shift the immune response away from the Th2 cell dominant asthmatic response. The question now is whether this also translates into a reduction of clinical symptoms in asthma patients.The primary objective of this study is to demonstrate clinical benefits of prolonged consumption of plant stanols (delivered via plant stanol esters) in asthma patients. The secondary objectives are to evaluate the mechanisms via which plant stanols modulate the immune system and to evaluate the effects of plant stanol ester consumption on cardiovascular (CVD) risk parameters.

Вмешательства

  • Пищевая добавка Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
    Soft chews containing 0.5g plant stanols delivered as plant stanol esters
  • Пищевая добавка Placebo soft chew
    Soft chew that does not contain plant stanols

Первичные конечные точки

  • Asthma control questionnaire score [Срок оценки: Change between T=0 months and T=12 months]
Вторичные конечные точки (12)
  • Asthma control questionnaire score [Срок оценки: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]
  • Forced expiratory volume in 1 second [Срок оценки: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]
  • Forced vital capacity [Срок оценки: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]
  • Asthma related medication use [Срок оценки: Throughout 1 year]
  • Number of visits to the general practitioner or hospital [Срок оценки: Throughout 1 year]
  • Incidence counts of exacerbations and other asthma related complaints [Срок оценки: Throughout 1 year]
  • Duration of exacerbations [Срок оценки: Throughout 1 year]
  • Severity of exacerbations [Срок оценки: Throughout 1 year]
  • Calculated disease load [Срок оценки: Throughout 1 year]
  • Number of infections that occur throughout the study [Срок оценки: Throughout 1 year]
  • Leukocyte count [Срок оценки: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]
  • Leukocyte differential count [Срок оценки: T=0 months, T=3 months, T=6 months, T=9 months, T=12 months]

Критерии участия

Критерии включения

  • Diagnosed with allergic asthma (GINA step 1-4) which is in a stable phase at the moment of inclusion (defined as no changes in asthma control and lung function in (at least) the past three months)
  • Have been treated with prescribed asthma medication for at least one year
  • Aged 18-70 years old
  • BMI between 20 and 35 kg/m2
  • Willing to abstain from products containing plant sterols or stanols one month prior to the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
  • Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
  • Willing to keep the intake of fish oil supplements constant

Критерии исключения

  • Currently smoking or quitted smoking in the past year, with a maximum of 10 packyears as smoking history (packyears = packs per day \* years of smoking)
  • Allergy to an ingredient of the soft chews
  • Suffering from inflammatory diseases (for CVD, illness must be minimally 3 years ago and currently under control in order to participate in the study)
  • Fasting plasma glucose > 7.0 mmol/L
  • Fasting serum TC > 8.0 mmol/L
  • Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
  • Pregnant women
  • Breastfeeding women

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Нидерланды · 1 центр
  • Maastricht University Medical Center — Maastricht

Идентификаторы

NCT: NCT03983603 · METC 18-064

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗