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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Hydrolysed Collagen supplement) | Experimental | 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. |
|
| Control Group (Standard Multidisciplinary Care) | Active Comparator | Participants receive standard multidisciplinary care without collagen supplementation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolysed Collagen (PROTÉGEN Plus) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Malnutrition status | 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. | Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects) |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional Biomarker (Serum albumin level) | Serum albumin concentration will be measured from fasting blood samples to assess improvement in nutritional biomarker status. Increased albumin levels indicate improved protein status following hydrolysed collagen supplementation compared with standard multidisciplinary care. | Baseline, Week 12, and Week 24 (follow-up for sustainability of effects) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farah Raihana Ghazi, BSc (Nutrition), MSc (Clinical | Contact | +60162262615 | raihanaghazi@gmail.com | |
| Noraida Omar, BSc(Dietetics), Ph.D(Nutrition | Contact | +60192252902 | noraidaomar@upm.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Noraida Omar, BSc(Dietetics), Ph.D(Nutrition | Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia | Serdang | Selangor | 43400 | Malaysia |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Standard Multidisciplinary Care | Other | 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. |
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| Body composition (skeletal muscle mass and fat-free mass) | Body composition-including skeletal muscle mass and fat-free mass-will be measured using bioelectrical impedance analysis (BIA). Changes will reflect improvement in overall muscle and bone tissue composition among older adults receiving hydrolysed collagen supplementation compared with standard multidisciplinary care. | Baseline, Week 12, and Week 24 (follow-up for sustainability of effects) |
| Functional capacity-Change in Short Physical Performance Battery (SPPB) score | Functional capacity will be assessed using the Short Physical Performance Battery (SPPB). These measures evaluate lower-extremity performance, balance, gait speed, and upper-body strength, collectively reflecting participants' physical function and rehabilitation progress. The SPPB consists of three components: balance tests, gait speed, and repeated chair stands. Scores range from 0 to 12, with higher scores indicating better physical performance. Improvements in these outcomes will be used to determine the added effect of hydrolysed collagen supplementation compared with standard multidisciplinary care alone. | 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 | Serum procollagen type I N-terminal propeptide (P1NP) will be measured as a marker of bone formation. Changes in P1NP levels reflect the bone synthesis. Improvements indicate enhanced bone metabolism following hydrolysed collagen supplementation compared with standard multidisciplinary care | Baseline, Week 12, and Week 24 (follow-up for sustainability of effects) |
| Functional capacity - Change in handgrip strength | Handgrip strength will be assessed using a hand-held dynamometer as a measure of muscle strength. Measurements will be obtained from the dominant hand, with the average of three trials recorded. Higher values indicate greater muscle strength. Units of measure is in Kilogram (Kg) | 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 | Serum C-terminal telopeptide of type I collagen (CTX) will be measured as a biochemical marker of bone resorption. Changes in CTX reflect alterations in bone resorption following hydrolysed collagen supplementation compared with standard multidisciplinary care. | Baseline, Week 12, and Week 24 |