MyNOURISH: Hydrolysed Collagen Supplementation in Older Adults With Fragility Fractures

Официальное название

MyNOURISH: Effectiveness of Hydrolysed Collagen on Nutritional, Functional, Body Composition and Bone Health Among Older Adults With Fragility Fractures in Hospital Sultan Abdul Aziz. .

Обзор

The goal of this clinical trial is to learn whether hydrolysed collagen supplementation (PROTÉGEN Plus) within multidisciplinary care can improve nutrition and recovery in older adults with fragility fractures. The main questions this study aims to answer are: 1. Does collagen supplementation improve malnutrition status, nutritional biomarker (albumin levels), body composition (skeletal muscle and fat-free mass), functional capacity and bone turnover (P1NP and CTX) over 12 weeks intervention period? 2. Does hydrolysed collagen supplementation have additional effects on the malnutrition status and functional capacity among older adult outpatients with fragility fractures at Week 6? 3. Are the effects of hydrolysed collagen supplementation on the malnutrition status, nutritional biomarker (albumin), body composition (skeletal muscle and fat-free mass), functional capacity, and bone turnover biomarkers (P1NP and CTX) sustained up to 24 weeks post-intervention compared to standard care? Researchers will compare two groups of older adults (aged 60 years and above) receiving care at Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia: \- Intervention group: Participants will receive hydrolysed collagen (PROTÉGEN Plus) with usual care within a multidisciplinary team for 12 weeks. Attend study visits at baseline, week 6, week 12, and week 24 (for follow-up of sustained effects). Keep a diary to record supplement intake, adherence, and any side effects, and return unopened supplement sachets at week 6 and 12 to monitor compliance. \- Control group: Participants will receive usual care within a multidisciplinary team. Attend study visits at baseline, week 6, week 12, and week 24 (for follow-up of sustained effects). This study will help researchers understand whether adding tilapia-derived collagen supplementation to multidisciplinary care can support better nutrition, muscle and bone health, and long-term recovery in older adults after a fragility fracture. It is hoped that the findings will strengthen the evidence for incorporating targeted nutritional strategies as part of fragility fracture management and secondary fracture prevention.

Вмешательства

• Пищевая добавка Hydrolysed Collagen (PROTÉGEN Plus)
  Participants will receive 15 g of hydrolysed tilapia collagen (PROTÉGEN Plus) daily for 12 weeks, in addition to usual care provided within a multidisciplinary team approach.
• Другое Standard Multidisciplinary Care
  Usual care consists of routine medical, nutritional, and rehabilitation management delivered through a multidisciplinary team approach at HSAAS, including follow-up medical reviews by physicians, personalised dietary counselling by dietitians, and tailored rehabilitation sessions conducted by physiotherapists.

Первичные конечные точки

• Malnutrition status [Срок оценки: Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)]

Вторичные конечные точки (6)

• Nutritional Biomarker (Serum albumin level) [Срок оценки: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)]
• Body composition (skeletal muscle mass and fat-free mass) [Срок оценки: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)]
• Functional capacity-Change in Short Physical Performance Battery (SPPB) score [Срок оценки: Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)]
• bone turnover biomarkers - Change in serum procollagen type I N-terminal propeptide (P1NP) levels [Срок оценки: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)]
• Functional capacity - Change in handgrip strength [Срок оценки: Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)]
• Bone Turnover Biomarker - Change in serum C-terminal telopeptide of type I collagen (CTX) levels [Срок оценки: Baseline, Week 12, and Week 24]

Критерии участия

Критерии включения

• Male or female participants aged 60 years and above.
• History of a fragility fracture (e.g., hip, wrist, or vertebral fracture) sustained within the past 12 months.
• Registered outpatient at Hospital Sultan Abdul Aziz Shah (HSAAS).
• Malaysian citizen.
• Able to communicate in Bahasa Malaysia or English.
• Able and willing to provide written informed consent.
• Cognitive function score >4 on the Elderly Cognitive Assessment Questionnaire (ECAQ).
• Currently undergoing a structured rehabilitation programme.
• May be receiving antiresorptive osteoporosis therapy or not receiving any osteoporosis pharmacological treatment at the time of recruitment.

Критерии исключения

• Cognitive impairment, defined as ECAQ score ≤4
• Metabolic bone diseases other than osteoporosis (e.g., Paget's disease, osteomalacia).
• Severe endocrine or metabolic disorders affecting bone metabolism (e.g., primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, hypogonadism, acromegaly).
• Terminal illness or palliative care needs (e.g., advanced cancer, end-stage organ failure, late-stage neurodegenerative diseases).
• Known allergy to fish, seafood, or collagen supplements, or diagnosis of phenylketonuria.
• Kidney disease, including history of kidney stones or chronic kidney disease stage 4-5 (estimated glomerular filtration rate <44 mL/min/1.73 m²).
• Participation in another interventional study that may interfere with the study protocol.
• Use of nutritional supplements during the study period.
• Prior use of collagen or amino acid-based supplements within the past 6 months.
• Non-ambulatory status prior to the fracture.
• Unstable medical conditions (e.g., uncontrolled arrhythmias, recent myocardial infarction, unstable angina, uncontrolled hypertension, pulmonary embolism).
• Current use of anabolic osteoporosis therapy.
• Alcohol dependence or active alcoholism.

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

Поддерживающая терапия

Центры проведения

Малайзия · 1 центр

• Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia — Serdang

Идентификаторы

NCT: NCT07347236 · MyNOURISH2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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