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Идёт набор NCT07528469

The Effects of PeptiStrong and Whey on Muscle Function In Older Adults

Без фазы С лечением Healthy Ageing Protein Supplementation Muscle Health Muscle Function

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: PeptiStrong + whey protein, Whey protein.
Кому может быть актуально
Состояния в реестре: Healthy Ageing, Protein Supplementation, Muscle Health, Muscle Function. Базовые параметры: 60 лет — 85 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
Великобритания
Следующий шаг
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Официальное название

The Effects of PeptiStrong and Low Dose Whey Protein Versus High Dose Whey Protein Alone on Muscle Function In Older Adults

Обзор

Examining the effects of PeptiStrong and protein on muscle function in older adults

Подробное описание

The aim of this study is to compare two protein drinks containing whey protein (derived from milk) in healthy adults aged 60 to 85 years. One group will consume a standard whey protein drink (20g), while the other group will consume a drink with half the total protein dose (10g) made of whey protein and PeptiStrong, a fava bean hydrolysate containing bioactive peptides.

The study will assess whether the lower protein drink containing PeptiStrong will lead to equal or greater improvements than the standard drink in physical function, such as the ability to stand up from a chair, walk at a normal pace, maintain balance, and grip strength. The study will also examine markers related to inflammation, fatigue, and quality of life.

The intended value of this research is to improve understanding of how targeted nutritional strategies may help maintain or improve muscle function in older adults. The findings may help inform future nutritional recommendations and the development of practical dietary interventions aimed at supporting healthy ageing and independence.

Вмешательства

  • Пищевая добавка PeptiStrong + whey protein
    Fava bean protein hydrolysate containing bioactive peptides mixed with whey protein as dry powder for drinkable protein shake
  • Пищевая добавка Whey protein
    Whey protein as dry powder for drinkable protein shake

Первичные конечные точки

  • Hand Grip Strength via hand held dynamometer [Срок оценки: Baseline to Week 4]
Вторичные конечные точки (10)
  • Chair Stand Test - Part of short performance physical battery [Срок оценки: Baseline to week 4]
  • Gait Speed as part of short performance physical battery [Срок оценки: Baseline to week 4]
  • 6 Minute Walking Endurance Test [Срок оценки: Baseline to week 4]
  • Balance test as part of short performance physical battery [Срок оценки: Baseline to week 4]
  • Balance assessment via force plates [Срок оценки: Baseline to week 4]
  • Quality of Life via the Sarcopenia Quality of Life (SarQoL®) Questionnaire [Срок оценки: Baseline to week 4]
  • Fatigue via Multidimensional Fatigue Inventory Questionnaire [Срок оценки: Baseline to week 4]
  • C-reactive protein (CRP) via blood test [Срок оценки: Baseline to week 4]
  • Interleukins via blood test [Срок оценки: Baseline to week 4]
  • Body composition: Muscle mass and body fat via bioelectrical impedance analysis [Срок оценки: Baseline to week 4]

Критерии участия

Критерии включения

  • Men and women aged 60 to 85 years at the time of enrolment
  • Community-dwelling (living independently or with minimal assistance)
  • Able to walk independently (with or without a walking aid) and complete simple physical function tests (such as standing up from a chair and walking short distances)
  • Willing and able to attend two study visits at the research facility (baseline and end of study)
  • Willing and able to consume a protein drink containing whey protein (derived from milk) once daily for 30 days
  • Able to understand the study information and provide written informed consent

Критерии исключения

  • Any known food allergy or intolerance to fava bean protein or milk protein
  • Diagnosed kidney disease or any medical condition where increased protein intake is contraindicated
  • Yes to any of the answers on the "Older Adult Functional Assessment Screening Questionnaire"
  • Individuals with implanted electronic devices
  • Current or recent (within the past 3 months) participation in another clinical research study involving a nutritional or exercise intervention
  • Conditions that significantly impair mobility or balance such that safe completion of the physical function tests is not possible

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
Четверное слепое
Основная цель
Другое

Центры проведения

Великобритания · 1 центр
  • LJMU, Byrom Street — Liverpool

Идентификаторы

NCT: NCT07528469 · PEPVFH+60/26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗