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Идёт набор NCT06950125

Evaluation of the JUICE HA® as an Anti-sarcopenia

Без фазы С лечением Sarcopenia in Elderly

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: Placebo, JUICE HA® supplement.
Кому может быть актуально
Состояния в реестре: Sarcopenia in Elderly. Базовые параметры: от 65 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study plans to recruit 60 participants aged 65 years and older who have been diagnosed with sarcopenia by a physician. Participants will be randomly assigned into JUICE HA® supplement and placebo group. All of the participants will be asked to take 15 mL/day of JUICE HA® supplement or placebo group for 12 weeks. The aim of this trial is to evaluate the potential of JUICE HA® to enhance physiological status (muscle mass and functional fitness) and to improve the quality of life in patients with sarcopenia.

Подробное описание

JUICE HA® is a nutritional supplement formulated with hyaluronic acid (HA), branched-chain amino acids (BCAA), and chondroitin. Hyaluronic acid contributes to enhancing hydration levels in the skin and connective tissues; BCAA promotes muscle protein synthesis and repair; and chondroitin is believed to support the structural integrity and functionality of joints. The synergistic combination of these components is anticipated to provide comprehensive, multidimensional support for individuals with sarcopenia, potentially alleviating symptoms and improving overall quality of life. Therefore, this study will explore 15 mL/day of JUICE HA® supplement to improve the muscle mass and functional fitness in the elderly with sarcopenia.

This study aims to recruit 60 participants aged 65 years and older who have been diagnosed with sarcopenia by a physician and meet the Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria. Participants will be enrolled in a randomized control-group pretest-posttest design and randomly assigned to receive either the JUICE HA® supplement or a placebo (Lin et al., 2021). Functional fitness assessments, the Sarcopenia Quality of Life questionnaire (SarQoL), and blood sample collections will be conducted at baseline, at the 6th and 12th weeks of the supplementation period, and at the 6th and 12th weeks of the follow-up period. Blood samples will be analyzed for oxidative stress markers (SOD, MDA), inflammatory markers (TNF-α, IL-10), and muscle synthesis and degradation indicators (mTOR, MuRF1, atrogin-1). Body composition assessments will be performed at baseline, at the 12th week of the supplementation period, and at the 12th week of the follow-up period.

Вмешательства

  • Другое Placebo
    Bottle of 15 mL liquid (non-effective product) will be taken once a day for 12 weeks.
  • Другое JUICE HA® supplement
    Bottle of 15 mL JUICE HA® supplement will be taken once a day for 12 weeks.

Первичные конечные точки

  • Grip Strength [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Chair Stand Test [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Appendicular Skeletal Muscle Mass (ASM) [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Appendicular Skeletal Muscle Mass Index [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Gait Speed [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Short Physical Performance Battery (SPPB) [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Sarcopenia Quality of Life (SarQoL) [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Clinical Biochemistry of total antioxidant capacity and lipid peroxidation [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Clinical Biochemistry of the inflammatory response [Срок оценки: From enrollment to the end of treatment at 24 weeks]
  • Clinical Biochemistry of biomarkers of muscle synthesis and degradation [Срок оценки: From enrollment to the end of treatment at 24 weeks]

Критерии участия

Критерии включения

  • Participants that have been diagnosed with sarcopenia by a physician and meet the AWGS 2019 criteria for sarcopenia.

Критерии исключения

  • Participants with a history of severe lower extremity musculoskeletal injuries within the past six months or those who have a fear of blood sampling will be excluded.

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
Четверное слепое
Основная цель
Другое

Центры проведения

Тайвань · 1 центр
  • China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT06950125 · CMUH114-REC3-004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗