Меню
Идёт набор NCT05480696

Soluble Fibre Supplementation in NAFLD

Фаза II С лечением Non-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Hepatic Steatosis

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: Fructo-oligosaccharide enriched inulin supplement, Maltodextrin.
Кому может быть актуально
Состояния в реестре: Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, Hepatic Steatosis. Базовые параметры: 8 лет — 17 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)

Обзор

The FIND study will look at the effect of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children with non-alcoholic fatty liver disease. In this randomized, double- blind controlled trial, subjects will be given a supplement, in the form of oral pills, and will have bloodwork performed, their diets analyzed, and liver fat measured at several timepoints. Liver fat will be measured by using a specialized MRI device located at St. Joseph's Hospital. Subjects will be recruited from the Children's Exercise and Nutrition Clinic.

Подробное описание

The FIND (Fibre in Non-Alcoholic Fatty Liver Disease) study will be a single-centre, randomized, double-blind placebo-controlled trial comparing the effects of 6 months of mixed oligofructose and inulin (OF+INU) supplementation vs placebo on hepatic fat content, hepatic stiffness, metabolic outcomes, and body composition in children ages 8-17 years old.

Assessments such as MRI measurements of hepatic fat and hepatic stiffness, anthropometry and pubertal status questionnaires, and other investigations such as body composition via dual energy X-ray absorptiometry (DXA), fasting lipids, liver enzymes, blood glucose and oral-glucose tolerance (OGTT) tests will be performed; and randomization will be conducted via REDCap software.

Eighty participants will be enrolled for baseline evaluation in order to randomize sixty participants for the intervention phase (i.e. thirty participants per study group). Participants will consume one packet (4g) of OF+INU or placebo (Maltodextrin) daily. If tolerated, this will increase to one packet twice daily. Several strategies will be implemented to increase compliance, including text message reminders (daily for first week, then weekly), study calls to assess compliance and tolerability, and check-ins with participants at each clinic visit. These interactions will allow the study team to assess challenges and offer prompt support. Compliance will be assessed at each study visit by counting empty and unused sachets. Treatment with OF+INU or placebo will occur for 6 months, with study visits being conducted at baseline evaluation, 3 months and 6 months

Вмешательства

  • Пищевая добавка Fructo-oligosaccharide enriched inulin supplement
    Experiment
  • Другое Maltodextrin
    Placebo.

Первичные конечные точки

  • Change in hepatic fat content. [Срок оценки: Six months]
Вторичные конечные точки (7)
  • Change in hepatic stiffness. [Срок оценки: Six months]
  • Change in glycemic control, or insulin resistance. [Срок оценки: Six months]
  • Change in liver enzymes (ALT, AST, GGT, or ALP) [Срок оценки: Six months]
  • Change in body fat percentage [Срок оценки: Six months]
  • Change in weight [Срок оценки: Six months]
  • Change in height [Срок оценки: Six months]
  • Change in BMI [Срок оценки: Six months]

Критерии участия

Критерии включения

  • Children ages 8-17 years
  • Diagnosed with obesity (BMI ≥2 standard deviations above WHO reference median)
  • Enrolled in GHWM Clinic
  • Clinical evidence of NAFLD (elevation of ALT, greater than 2x upper-limit-of-normal (ULN) \[ALT>80 IU/L for 8-17 years of age\], and hepatic steatosis measured as part of clinic enrolment).

Критерии исключения

  • Type 1, Type 2 diabetes mellitus (T1DM, T2DM)
  • Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight > 300lbs)
  • Concomitant use of other fibre supplements
  • Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants, antipsychotics, glucose- lowering medications)
  • Presence of another known cause of liver disease
  • Known allergy or hypersensitivity to OF-INU supplementation
  • Self-reported alcohol intake >7 drinks/week or 3 drinks/day

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • McMaster University Medical Center — Hamilton

Идентификаторы

NCT: NCT05480696 · 14888 · 471270

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗