- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03035799
Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Maryland
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Baltimore, Maryland, Соединенные Штаты, 21287
- Johns Hopkins University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate anxiety or depression
- Other causes of bowel symptoms excluded to the satisfaction of the Study Team
- Age at least 18 years at initial screening visit
- Patients who are able to sign and understand the study's informed consent form
- Patients able to complete all screening evaluations and procedures
Exclusion Criteria:
- Patients in inpatient hospital care
- Severe or refractory bowel or psychological symptoms
- Current consumption of a Paleolithic diet
- Known Celiac disease
- Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (TSH) level
- Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater
- Patients unable to speak English
- Inability to obtain informed consent
- Pregnant or nursing women
- Any condition, which in the opinion of the investigator, would interfere with study requirements
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Paleolithic Diet
|
Paleolithic diet
|
Активный компаратор: General Healthful Diet
|
General Healthful Diet
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Vitality
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Vitality as measured on the vitality subscale of the short form health survey (SF36).
This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys.
The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life?
Did you have a lot of energy?
Did you feel worn out?
Did you feel tired?
The lower the score the more disability.
The higher the score the less disability.
|
The change between baseline and 4 weeks (post-intervention).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Anxiety
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
|
Depression
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire. PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
|
Activity level
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire.
The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise.
It is designed to be reliable valid and easy to complete quickly without a need for detailed review.
Lower scores indicate less activity and higher scores equal more activity.
|
The change between baseline and 4 weeks (post-intervention).
|
Gastrointestinal symptoms
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
|
Visceral sensitivity
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Visceral sensitivity as measured by the Visceral Sensitivity Index.
Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
|
The change between baseline and 4 weeks (post-intervention).
|
Overall health status (Short Health Scale)
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Overall health status as measured by the Short Health Scale questionnaires.
The "Short Health Scale" is a 4-item questionnaire covering aspects of subjective health.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
|
The change between baseline and 4 weeks (post-intervention).
|
Overall health status (EQ-5D)
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression.
Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive
system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
|
The change between baseline and 4 weeks (post-intervention).
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Intestinal permeability
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Change in intestinal permeability as measured by plasma zonulin levels
|
The change between baseline and 4 weeks (post-intervention).
|
Change in inflammatory markers
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Change in inflammatory markers as measured by serum C-reactive protein levels
|
The change between baseline and 4 weeks (post-intervention).
|
Change in stool metabolomics
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Change in stool metabolomics as measured by stool metabolite testing.
|
The change between baseline and 4 weeks (post-intervention).
|
Change in stool microbiome profile
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.
|
The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of urine.
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
|
The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool.
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
|
The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of saliva.
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
|
The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of blood.
Временное ограничение: The change between baseline and 4 weeks (post-intervention).
|
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
|
The change between baseline and 4 weeks (post-intervention).
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB00082222
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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