Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia
Serdang, Selangor, 43400, Malaysia
Location contact
Farah Raihana Ghazi, BSc (Nutrition), MSc (Clinical
CONTACT
Noraida Omar, BSc(Dietetics), Ph.D(Nutrition
CONTACT
NCT Number: NCT07347236
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Serdang, Selangor, 43400, Malaysia
Farah Raihana Ghazi, BSc (Nutrition), MSc (Clinical
CONTACT
Noraida Omar, BSc(Dietetics), Ph.D(Nutrition
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)
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.
Time frame: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)
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.
Time frame: Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)
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.
Time frame: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)
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
Time frame: Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)
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)
Time frame: Baseline, Week 12, and Week 24
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.
Contact information is provided by the study sponsor or research team.
Farah Raihana Ghazi, BSc (Nutrition), MSc (Clinical
CONTACT
Noraida Omar, BSc(Dietetics), Ph.D(Nutrition
CONTACT
Hospital Pengajar Universiti Putra Malaysia
Other
MyNOURISH: Effectiveness of Hydrolysed Collagen on Nutritional, Functional, Body Composition and Bone Health Among Older Adults With Fragility Fractures in Hospital Sultan Abdul Aziz. .
Acronym: MyNOURISH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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