The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease

Официальное название

The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial

Обзор

The goal of this clinical trial is to determine whether increasing protein intake in elderly adults with pre-dialysis chronic kidney disease, in combination with resistance exercise, improves muscle mass without worsening renal function.The main questions it aims to answer are: * Does a protein intake of 1.2 g/kg BW/day combined with exercise improve muscle mass better than a protein intake of 1.0 g/kg BW/day? * Does a protein intake of 1.2 g/kg BW/day combined with exercise lead to greater improvements in muscle strength and function? * Does a protein intake of 1.2 1.2 g/kg BW/day combined with exercise cause a decline in renal function (eGFR) compared to a protein intake of 1.0 1.2 g/kg BW/day? Researchers will compare a group assigned to intake 1.2 g/kg BW/day of protein with another group assigned to intake 1.0 g/kg BW/day, to assess whether the higher intake improves muscle mass and physical performance without causing harm. Participants will * be assessed for body composition, physical performance and nutritional intake. * be assigned to consume protein at either 1.2 or 1.0 g/kg/day. * perform a home-based resistance exercise program using resistance bands. * provide blood and urine sample to monitor renal function. * visit the clinic at weeks 12 and 24 for repeated measurement.

Вмешательства

• Поведенческое Protein intake 1.2 g/kg/day and resistance exercise
  Protein intake of 1.2 g/kg/day in combination with resistance exercise using resistance bands
• Поведенческое Protein intake 1.0 g/kg/day and resistance exercise
  Protein intake 1.0 g/kg/day in combination with resistance exercise using resistance bands

Первичные конечные точки

• Between-Group Differences in Muscle Mass Changes at 6 Months [Срок оценки: From enrollment to the end of intervention at 24 weeks]

Критерии участия

Критерии включения

• Thai adults aged ≥ 65 years
• Chronic kidney disease with estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m2
• Sarcopenia or presarcopenia (diagnosis based on Asian Working Group for Sarcopenia (AWGS) 2019 definition)

Критерии исключения

• Active cardiopulmonary disease(s) or uncontrolled hypertension with contraindications to resistance training
• Physically or cognitively unable to participate in the resistance exercise program (e.g. dementia), as determined by the attending physician
• Limitations of body measurements and interpretation using Bioelectrical Impedance Analysis (BIA) e.g. presence of pacemaker, surgical metal implants
• Meets the definition of AKI or AKD, defined as alterations in kidney function within the past 3 months
• Severe vitamin D deficiency (25-OH Vitamin D level < 10 ng/mL)
• Refuses to give consent to participate in the study

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

Таиланд · 1 центр

• King Chulalongkorn Memorial Hospital — Bangkok

Идентификаторы

NCT: NCT07102667 · 0182/68

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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