Fragility FractureMyNOURISHNCT07347236
MyNOURISH: Hydrolysed Collagen Supplementation in Older Adults With Fragility Fractures
A study testing Hydrolysed Collagen (PROTÉGEN Plus) and Standard Multidisciplinary Care in people with Fragility Fracture, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fragility Fracture
- What is being tested?
- Hydrolysed Collagen (PROTÉGEN Plus) and Standard Multidisciplinary Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia
Serdang, Selangor, 43400
Farah Raihana Ghazi, BSc (Nutrition), MSc (Clinical, +60162262615, raihanaghazi@gmail.com
Noraida Omar, BSc(Dietetics), Ph.D(Nutrition, +60192252902, noraidaomar@upm.edu.my
About this study
Official title: MyNOURISH: Effectiveness of Hydrolysed Collagen on Nutritional, Functional, Body Composition and Bone Health Among Older Adults With Fragility Fractures in Hospital Sultan Abdul Aziz. .
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:
Read more
- 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.
- Conditions
- Fragility Fracture
- Being tested
- Hydrolysed Collagen (PROTÉGEN Plus), Standard Multidisciplinary Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard Multidisciplinary CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Hydrolysed Collagen (PROTÉGEN Plus) |
| Control Group (Standard Multidisciplinary Care) | Active comparator | Participants receive standard multidisciplinary care without collagen supplementation. Receives: Other: Standard Multidisciplinary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)
Secondary outcomes (6)
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.
Measured: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)
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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: Baseline, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fragility FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Pengajar Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noraida Omar, BSc(Dietetics), Ph.D(Nutrition, Principal investigator, Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347236
- Sponsor's protocol ID
- MyNOURISH2025
- Acronym
- MyNOURISH
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyNOURISH: Effectiveness of Hydrolysed Collagen on Nutritional, Functional, Body Composition and Bone Health Among Older Adults With Fragility Fractures in Hospital Sultan Abdul Aziz. .
- ClinicalTrials.gov ID
- NCT07347236
- Acronym / sponsor ID
- MyNOURISH / MyNOURISH2025
- Conditions
- Fragility Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hospital Pengajar Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Hydrolysed Collagen supplement) | Experimental | Dietary Supplement: Hydrolysed Collagen (PROTÉGEN Plus)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 | Other: Standard Multidisciplinary CareParticipants receive standard multidisciplinary care without collagen supplementation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Intervention Group (Hydrolysed Collagen supplement) |
| Standard Multidisciplinary CareUsual 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. | Other | Control Group (Standard Multidisciplinary Care) |
Primary outcome
Malnutrition status
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.
6 secondary outcomes
Nutritional Biomarker (Serum albumin level)
Time frame: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)
Body composition (skeletal muscle mass and fat-free mass)
Time frame: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)
Functional capacity-Change in Short Physical Performance Battery (SPPB) score
Time frame: 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
Time frame: Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)
Functional capacity - Change in handgrip strength
Time frame: 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
Time frame: Baseline, Week 12, and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noraida Omar, BSc(Dietetics), Ph.D(Nutrition principal investigator
Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolysed Collagen (PROTÉGEN Plus) and Standard Multidisciplinary Care in people with Fragility Fracture, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farah Raihana Ghazi, BSc (Nutrition), MSc (Clinical (+60162262615, raihanaghazi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition status (time frame: Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.