- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07586111
Effects of Plant Foods on Gastrointestinal and Cardiometabolic Health (PLANTIFUL)
A Randomised Controlled Trial Investigating the Impact of Plant Foods on Gastrointestinal and Cardiometabolic Health
The aim of this randomised controlled trial is to investigate the effects of plant foods on gastrointestinal and cardiometabolic health in healthy adults aged 30-70 years old. The main question it will answer is "what is the effect of plant foods on alpha-diversity of the gut microbiota?".
Researchers will compare two diets containing plant foods to see if they have different effects on gastrointestinal and cardiometabolic health.
Participants will be asked to replace all their meals, snacks and drinks with those provided by the study team for four weeks (6 days/week). Participants will also be asked to attend the research facility on three occasions to:
- Provide a blood sample
- Provide a urine sample
- Provide a stool sample
- Have their body composition assessed
- Have an ultrasound of their artery (arm)
- Have their blood pressure measured
- Answer questionnaires related to dietary intake, mental health, physical activity, quality of life, diet acceptability and adherence
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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London, Соединенное Королевство, SE1 9NH
- Рекрутинг
- King's College London
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Контакт:
- Clinical Trial Manager
- Номер телефона: +442078484552
- Электронная почта: plantiful@kcl.ac.uk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Adults aged 30-70 years of age
- Capacity to give informed consent in English
- Consume equal or less than the average UK plant food intake (number and quantity)
- Consume less than 30 g/d of fibre
- BMI 18.50-29.99 kg/m2
- Willing to complete the trial by adhering to the diet intervention, complete questionnaires, provide stool, urine and blood samples, record weight and other anthropometric values and record food intake throughout the study
- Willing and able to adhere to the protocol for the diet intervention for the whole duration of the trial (e.g., appropriate space in freezer to store meals, access to oven/microwave, no planned travelling)
- Willing to discontinue use of prebiotics and probiotics 4 weeks prior and during the intervention period
- Willing to consume animal products daily
- Medication use is stable in women receiving hormone replacement therapy (stable use for the past 3 months)
Exclusion Criteria:
- Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g., schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.
- A current diagnosis of IBS, as defined by the Rome IV criteria.
- Taking medications known to affect outcomes of interest, including:
- Prebiotics and probiotics 4 weeks prior to enrolment.
- Antibiotics within 4 weeks of enrolment.
- Medications known to affect blood pressure, appetite, gut motility, glucose control, or lipid levels within 4 weeks of enrolment.
- Taking any dietary supplements, apart from vitamin D or calcium supplements, 4 weeks prior to enrolment.
- Allergy or intolerance to any study food ingredients.
- Unable/dislike/unwilling to consume study foods or adhere to study protocol (e.g., not willing to drink a maximum 9 units of alcohol a week or consume animal products).
- Currently reported pregnant or lactating.
- Unwilling or unable to consume non-halal or non-kosher products.
- Estimated energy requirements of <1,500 kcal/day or >3,000 kcal/day.
- Unexplained or unintentional weight loss in the past six months.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Study Diet A
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
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Study meals, snacks and drinks will be provided that contain plant foods for four weeks (6 days a week).
Participants will follow guidance in self-selecting foods on one day per week.
Другие имена:
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Активный компаратор: Study Diet B
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
|
Study meals, snacks and drinks will be provided that contain plant foods for four weeks (6 days a week).
Participants will follow guidance in self-selecting foods on one day per week.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Alpha-diversity of the gut microbiota
Временное ограничение: Week 4
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The diversity of microbial taxa in faecal samples at 4 weeks assessed by calculating alpha-diversity score from 16S ribosomal RNA sequencing.
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Week 4
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Absolute and change in alpha-diversity of the gut microbiota
Временное ограничение: Baseline, Week 4
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Absolute and change in alpha-diversity as measured by the diversity of micriobial taxa in faecal samples via 16S RNA sequencing.
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Baseline, Week 4
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Beta-diversity of the gut microbiota
Временное ограничение: Baseline, Week 4
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The diversity of microbial taxa in faecal samples by calculating beta-diversity via 16S ribosomal RNA sequencing.
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Baseline, Week 4
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Microbiota composition
Временное ограничение: Baseline, Week 4
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Absolute and change in microbiota composition of faecal samples between baseline and Week 4 as assessed by 16S ribosomal RNA sequencing.
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Baseline, Week 4
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Targeted faecal and plasma metabolomics
Временное ограничение: Baseline, Week 4
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Absolute and change in short-chain fatty acids through Liquid Chromatography - Mass Spectrometry using validated assays.
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Baseline, Week 4
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Targeted faecal and plasma metabolomics
Временное ограничение: Baseline, Week 4
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Absolute and change in bile acids through Liquid Chromatography - Mass Spectrometry using validated assays.
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Baseline, Week 4
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Untargeted faecal metabolomics
Временное ограничение: Baseline, Week 4
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Metabolomics analysis via 1H NMR spectroscopy.
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Baseline, Week 4
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Faecal water content via oven drying
Временное ограничение: Baseline, Week 4
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Absolute and change in water content of faecal samples assessed via oven drying.
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Baseline, Week 4
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Stool frequency
Временное ограничение: Baseline, Week 4
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Absolute and change in stool frequency measured via prospective 7-day stool diary
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Baseline, Week 4
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Stool consistency
Временное ограничение: Baseline, Week 4
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Absolute and change in stool consistency measured by Bristol stool form scale. Scale from 1 to 7.
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Baseline, Week 4
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Gastrointestinal symptoms
Временное ограничение: Baseline, Week 4
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Absolute and change in gastrointestincal symptons measured by Gastrointestinal symptoms rating scale score.
Scored from 15 to 105 with lower scores indicating less severe symptoms.
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Baseline, Week 4
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Endothelial function
Временное ограничение: Baseline, Week 4
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Flow mediated dilation measured via ultrasound of arm.
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Baseline, Week 4
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Untargeted urine and plasma metabolomics
Временное ограничение: Baseline, Week 4
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Metabolomics measured via 1H NMR spectroscopy.
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Baseline, Week 4
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Targeted plasma and urine metabolomics
Временное ограничение: Baseline, Week 4
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Metabolomics via Liquid Chromatography-Mass Spectroscopy using validated assays.
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Baseline, Week 4
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Blood pressure
Временное ограничение: Baseline, Week 4
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Absolute and change in diastolic and systolic blood pressure.
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Baseline, Week 4
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Body composition
Временное ограничение: Baseline, Week 4
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Absolute and change in body composition measured via biolelectrical impedance analysis (BIA).
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Baseline, Week 4
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Waist circumference
Временное ограничение: Baseline, Week 4
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Absolute and change in waist circumference assessed by tape measure.
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Baseline, Week 4
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Dietary intake
Временное ограничение: Baseline, Week 4
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Dietary intake measured by aggregating EPIC Norfolk food frequency questionnaire, daily food and drink diaries and food checklists.
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Baseline, Week 4
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Biological markers of dietary intake
Временное ограничение: Baseline, Week 4
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Absolute and change in biomarkers of dietary intake as measured via validated assays.
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Baseline, Week 4
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Health-related Quality of Life
Временное ограничение: Baseline, Week 4
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Absolute and change in SF-36 questionnaire scores.
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Baseline, Week 4
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Mental Health
Временное ограничение: Baseline, Week 4
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Absolute and change in Patient Health Questionnaire-8 and Anxiety and Depression Scale scores.
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Baseline, Week 4
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Diet acceptability
Временное ограничение: Baseline, Week 4
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Acceptability of diet measured through a diet acceptability questionnaire containing multiple choice and open-ended questions.
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Baseline, Week 4
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Diet satisfaction
Временное ограничение: Week 4
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Absolute diet satisfaction measured by Food benefits assessment scale.
Scored from 41 to 205 with a lower score indicating a higher diet satisfaction.
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Week 4
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Dietary adherence
Временное ограничение: Baseline, Week 4
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Adherence to the intervention as measured by consumption of study meals, snacks and drinks.
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Baseline, Week 4
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Соавторы и исследователи
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- HR-25/26-49752
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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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. .