Меню
Идёт набор NCT05040204

The Effects of Dietary Supplementation on Serum Protein Glycosylation

Фаза I С лечением Healthy

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: Monosaccharide Powder, Placebo Comparator.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 18 лет — 45 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
США
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 →

Обзор

Two randomized double-blind placebo-controlled clinical studies to assess the effects of dietary glycan monomer supplementation on the immune system, especially antibody glycosylation in healthy adults. Immune profiling and glycoproteomics will be performed on serum isolated at these same time points.

Вмешательства

  • Пищевая добавка Monosaccharide Powder
    Monosaccharide powder dissolved in water.
  • Пищевая добавка Placebo Comparator
    Placebo (glucose powder)

Первичные конечные точки

  • Characterize Immunoglobulin fragment crystallization modifications [Срок оценки: 4 Weeks]
Вторичные конечные точки (4)
  • Assess for potential adverse events [Срок оценки: 2 months after first dose]
  • Quantification of enzymatic modifications measured in grams by spectrometry [Срок оценки: 6 months]
  • Flow cytometry to determine the effect of dietary supplementation on the immune system [Срок оценки: 6 months]
  • Transcriptome analysis to determine the effect of dietary supplementation on the immune system [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Adult men/women (age 18-45) who are in general good health with Body Mass Index (BMI) range of 18.5-25

Критерии исключения

  • Adults younger than 18 or older than 45 years of age
  • Women who are pregnant, actively nursing or have had a pregnancy within the last year
  • Women who are peri-menopausal or post-menopausal
  • Women with irregular menstrual cycles (more frequently than every 21 days or lasts longer than 8 days. Missed, early, or late periods are also considered signs of an irregular cycle)
  • Women on hormonal contraception, including birth control, hormonal intrauterine device, or contraceptive implant
  • Individuals with past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer
  • Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any type
  • Individuals with diagnosis of galactosemia or congenital disorders of glycosylation
  • Individuals with phenylketonuria
  • Individuals currently taking prescription medications, or who have taken prescription medications within the last 3 months
  • Individuals currently taking over-the-counter medications
  • Individuals currently taking or who have taken supplements including herbal, protein or vitamin supplements in the last 3 months (e.g. whey protein, St. John's Wort, green tea supplements, biotin, creatine supplements), excluding multivitamins or essential vitamins
  • Individuals with BMI less than 18.5 or greater than 25
  • Individuals with prior history of severe food or drug allergic reactions
  • Individuals with allergic reaction or adverse reaction to shellfish, N-acetylglucosamine, galactose, Spirulina/chlorella/algae supplements, or arabinose containing compounds/foods/supplements
  • Individuals with first-degree relative with history of an autoimmune condition
  • Individuals with social history of current use of tobacco, alcohol or other drugs
  • Individuals with dietary restrictions (vegetarians are permitted to participate in the study) or atypical exercise patterns, or to whom any of the following dietary habits or characteristics apply (the following exclusion criteria are placed to minimize variability in diet/exercise patterns in our pilot study population):
  • Actively dieting or trying to lose weight
  • Vegan diet
  • Consume equal to or greater than 2 cups of tea a day
  • Consume equal to or greater than 4 cups of coffee a day
  • Consume equal to or greater than 3 cups of fruit juice a day
  • Practice intensive exercise patterns (marathon training, workouts >4 hours a day)
  • Consume soda or energy drinks of any amount
  • Consume fast food equal to or greater than 5 days per week
  • Consume greater than one serving of alcohol per day
  • (1 serving of wine = 6 oz, 1 serving of beer = 12 oz, 1 serving of spirits = 1 oz)
  • On a carbohydrate-restricted or "Paleo" diet, or calorie-restricted diet (less than 20-25% of maintenance calories)
  • Adults unable to consent
  • Prisoners

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
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of California, Davis Medical Center — Sacramento

Идентификаторы

NCT: NCT05040204 · 949221 · 1K24AR077313-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗