MyNOURISH: Hydrolysed Collagen Supplementation in Older Adults With Fragility Fractures
NCT ID: NCT07347236
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
76 participants
INTERVENTIONAL
2026-01-31
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Move Study in Healthy Aging People
NCT02276183
Bone Intake Proteins and Muscle Mass Deficiency in Proximal Femur Fractures
NCT05804604
Hohenheim Malnutrition Study in Geriatric Fracture Patients
NCT03493100
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
NCT06567054
An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
NCT03882944
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Control Group (Standard Multidisciplinary Care)
Participants receive standard multidisciplinary care without collagen supplementation.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Pengajar Universiti Putra Malaysia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Noraida Omar, BSc(Dietetics), Ph.D(Nutrition
Role: PRINCIPAL_INVESTIGATOR
Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia
Serdang, Selangor, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MyNOURISH2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.