MyNOURISH: Hydrolysed Collagen Supplementation in Older Adults With Fragility Fractures

NCT07347236 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-01-16

No results posted yet for this study

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. 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.

Conditions

  • Fragility Fracture

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • Hospital Pengajar Universiti Putra Malaysia

    lead OTHER

Principal Investigators

  • Noraida Omar, BSc(Dietetics), Ph.D(Nutrition · Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-03-31
Completion
2027-06-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347236 on ClinicalTrials.gov