MyNOURISH: Hydrolysed Collagen Supplementation in Older Adults With Fragility Fractures

NCT07347236 | Not Yet Recruiting

• 1 other identifier: MyNOURISH2025
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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?

Conditions

Fragility Fracture

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Nutritional Biomarker (Serum albumin level)

  Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)

• Body composition (skeletal muscle mass and fat-free mass)

  Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)

• Functional capacity-Change in Short Physical Performance Battery (SPPB) score

  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

  Baseline, Week 12, and Week 24 (follow-up for sustainability of effects)

• Functional capacity - Change in handgrip strength

  Baseline, Week 6, Week 12, and Week 24 (follow-up for sustainability of effects)

Study Arms (2)

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.

Dietary Supplement: Hydrolysed Collagen (PROTÉGEN Plus)

Control Group (Standard Multidisciplinary Care)

ACTIVE COMPARATOR

Participants receive standard multidisciplinary care without collagen supplementation.

Other: Standard Multidisciplinary Care

Interventions

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.

Intervention Group (Hydrolysed Collagen supplement)

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.

Control Group (Standard Multidisciplinary Care)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Hospital Pengajar Universiti Putra Malaysia: lead

Study Sites (1)

Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

Related Links

• Related Info

Study Officials

• Noraida Omar, BSc(Dietetics), Ph.D(Nutrition

  Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)