MyNOURISH: Effectiveness of Hydrolysed Collagen on Nutritional, Functional, Body Composition and Bone Health Among Older Adults With Fragility Fractures in Hospital Sultan Abdul Aziz. .
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Malnutrition status
研究概览
简要总结
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:
- 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?
- Does hydrolysed collagen supplementation have additional effects on the malnutrition status and functional capacity among older adult outpatients with fragility fractures at Week 6?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group (Hydrolysed Collagen supplement)
Participants in this group will receive 15 g of hydrolysed tilapia collagen (PROTÉGEN Plus) daily for 12 weeks. Participants will attend follow-up assessments at baseline, week 6, week 12, and week 24 to monitor adherence, safety, and outcomes. Unopened supplement sachets will be returned at week 6 and 12 to assess compliance.
干预措施: Hydrolysed Collagen (PROTÉGEN Plus) (Dietary Supplement)
Control Group (Standard Multidisciplinary Care)
Participants receive standard multidisciplinary care without collagen supplementation.
干预措施: Standard Multidisciplinary Care (Other)
结局指标
主要结局
Malnutrition status
时间窗: Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)
Malnutrition status will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF). The score categorizes participants as well-nourished, at risk of malnutrition, or malnourished. The study will evaluate the improvement in malnutrition status through the scoring on each timepoints, following hydrolysed collagen supplementation compared with standard multidisciplinary care.
次要结局
- Nutritional Biomarker (Serum albumin level)(Baseline, Week 12, and Week 24 (follow-up for sustainability of effects))
- Body composition (skeletal muscle mass and fat-free mass)(Baseline, Week 12, and Week 24 (follow-up for sustainability of effects))
- Functional capacity-Change in Short Physical Performance Battery (SPPB) score(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(Baseline, Week 12, and Week 24 (follow-up for sustainability of effects))
- Functional capacity - Change in handgrip strength(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(Baseline, Week 12, and Week 24)