Feasibility Testing of Plant-Based Meal Replacement Products Made With Manitoba Crop Ingredients for Weight Loss and Diabetes Remission
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: Meal Replacement.
- Кому может быть актуально
- Состояния в реестре: Weight Loss, Prediabetes, Diabetes. Базовые параметры: от 18 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 →
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Обзор
The goal of this clinical trial is to advance the development of the WI meal replacements by evaluating the acceptance and feasibility of the meal replacements within the Wellness Institute's Weight Loss Clinic program (WLC). The main questions it aims to answer are: * To determine whether the incorporation of WI meal replacements into their weight loss clinic design is feasible. * To determine whether weight loss is supported by a plant-based meal replacement. * To assess efficacy of the meal replacements by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-meal replacement weight loss program members. * To assess remission of diabetes and pre-diabetes. Researchers will compare the WLC program plus meal replacements to the WLC program without the meal replacements to evaluate the implementation of the meal replacements into the WLC. Participants will follow their WLC program for 16 weeks, and those in the intervention group will begin their meal replacements. Participants will have a choice on what type of meal replacement they will consume each day (either a bar or a shake) and will record this in the product consumption log.
Вмешательства
- Пищевая добавка Meal Replacement
These meal replacements provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.
Первичные конечные точки
- Feasibility of incorporating the WI meal replacements into their weight loss clinic design. [Срок оценки: At Enrollment (Week 0) and End of Study (Week 16)]
Вторичные конечные точки (7)
- Changes in Body Weight [Срок оценки: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes in Waist Circumference [Срок оценки: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes in BMI [Срок оценки: At Enrollment (Week 0) and End of Study (Week 16)]
- Cardiovascular Assessment [Срок оценки: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes is Quality of Life [Срок оценки: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes in Medication [Срок оценки: At Enrollment (Week 0) and End of Study (Week 16)]
- Changes in HemaglobinA1C [Срок оценки: At Enrollment (Week 0) and End of Study (Week 16)]
Критерии участия
Критерии включения
- Male or female, aged 18 years or above
- Live within the province of MB
- Ability to give written informed consent in English.
- Enrolled in the Wellness Institute Weight Loss Clinic
Критерии исключения
- Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
- Participants with known allergies to the meal replacement ingredients
- Has an active eating disorder
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Канада · 1 центр
- Seven Oaks Hospital Chronic Disease Innovation Centre — Winnipeg
Идентификаторы
NCT: NCT06614543 · HS26095 (B2023:073)