Feasibility of Adding a Plant-Based Protein Pudding to the Diet of Older Adults Who Attend a Medically Managed Fitness Facility
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: Plant Based pudding.
- Кому может быть актуально
- Состояния в реестре: Feasibility Studies, Nutrition Intervention. Базовые параметры: от 60 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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Официальное название
Evaluation of a Plant-based Protein Pudding In Older Adults Attending a Medically Managed Fitness Facility
Обзор
The goal of this a 12-week randomized controlled parallel arm feasibility trial is to evaluate the feasibility and acceptability of incorporating a plant-based protein pudding into the diets of older adults who attend a medically managed fitness facility. The primary participant population includes older adults, aged 60 years and above, who are generally healthy and engaged in structured fitness programs. The main questions it aims to answer are: Is a plant-based protein pudding acceptable and well-tolerated by older adults? Does regular consumption of the pudding support muscle health and overall well-being in this population? Participants will: Consume a plant-based protein pudding as one arm daily for 7 days per week (experimental) and the other will continue their current lifestyle (control). The experimental group will complete surveys or questionnaires to assess acceptability, taste, and ease of integration into daily meals. Undergo basic physical or health assessments (e.g., muscle function or strength evaluations) to evaluate potential effects.
Вмешательства
- Пищевая добавка Plant Based pudding
Will consume one high protein plant based pudding daily for 7-days per week for 12 weeks
Первичные конечные точки
- Eligibility to Randomization Ratio for Feasibility [Срок оценки: Measured upon study completion after 12-weeks]
- Recruitment Rate [Срок оценки: during 12 months]
- Follow up rate [Срок оценки: Measured at end of 12 weeks]
- Adherence to Intervention [Срок оценки: Measured at the end of 12 weeks]
Вторичные конечные точки (12)
- Serum Pre-Albumin [Срок оценки: Measured at Baseline Week 1 and at the end of 12 weeks.]
- Blood Amino Acid Profile [Срок оценки: Measured at Baseline Week 1 and at the end of week 12]
- Dry Weight [Срок оценки: Measured at Baseline Week 1 and after the end of week 12]
- Waist Circumsference [Срок оценки: Measured at Baseline Week 1 and after the end of week 12]
- Lean mass [Срок оценки: At the baseline week 1 and at end of week 12]
- Fat Mass [Срок оценки: At the baseline week 1 and at end of week 12]
- Physical function; Five rep chair stand time test [Срок оценки: Measured at Baseline Week 1 and after the end of week 12]
- Blood Pressure [Срок оценки: Measured at Baseline Week 1 and after the end of week 12]
- Total Calories intake [Срок оценки: Measured at Baseline Week 1 and after the end of week 12]
- Carbohydrates [Срок оценки: At the baseline week 1 and at end of week 12]
- Protein [Срок оценки: At the baseline week 1 and at end of week 12]
- Fat [Срок оценки: At the baseline week 1 and at end of week 12]
Критерии участия
Критерии включения
- Participant is willing and able to give informed consent for participation in the trial
- Male or female aged ≥60 years
- Actively attend the Wellness Institute (≥8 times in the past 28 days),
Критерии исключения
- Allergy to ingredients in the study treatment
- Inability to consume treatment product
- Inability to obtain written informed consent
- Apart of any physical rehab program at WI (cardiac rehab, kidney fit, etc. )
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
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Канада · 1 центр
- Chronic Disease Innovation Centre — Winnipeg
Идентификаторы
NCT: NCT07142694 · HS26887 (B2025:025)