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Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty

NCT07780006 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-21

No results posted yet for this study

Summary

This study aim to compare the efficacy of oral nutritional supplementation (ONS) in femoral neck fracture patients undergoing hip arthroplasty compared with placebo. The hypothesis is "Oral nutritional supplement with Beta-hydroxy-beta-methylbutyrate (HMB) can improve muscle strength in femoral neck fracture patients undergoing hip arthroplasty".

Femoral neck fracture patients aged more than 65 years will be enrolled and allocated into 2 groups

* ONS group: Oral nutritional supplement (Ensure® Plus Advance) 2 serves / day x 30 days + Standard oral intake
* Control group: Standard oral intake

Primary outcome is Grip strength, assessed using hand dynamometer on admission and 2, 6, 12 weeks postoperatively.

Secondary outcomes are

* Serum albumin assessed on admission and 2, 6, 12 weeks postoperatively
* Barthel index assessed at 2, 6, 12 weeks postoperatively
* Mini Nutritional Assessment (MNA), Geriatric Nutritional Risk Index (GNRI) assessed at 2, 6, 12 weeks postoperatively
* Length of stay (day)
* Time up and go (TUG), assessed at 2, 6, 12 weeks postoperatively
* Oxford hip score (OHS), assessed at 2, 6, 12 weeks postoperatively
* Complications, rate of readmission, mortality rate assessed until 3 months

Conditions

  • Femoral Neck Fractures
  • Geriatric Hip Fracture
  • Hip Fracture, Post Surgery Recovery, Muscle Resilience

Interventions

DIETARY_SUPPLEMENT

Oral nutritional supplementation

Oral nutritional supplement that consists of 20 grams of protein, 1.5 grams of calcium β-hydroxy-β-methylbutyrate (CaHMB), 0.5 gram of calcium, 500 international units (IU) of vitamin D and calories of 330 kcal per one bottle of 220 ml (Ensure® Advance Plus, Abbott Laboratorios S.A.)

Sponsors & Collaborators

  • Thammasat University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Thailand

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 NCT07780006 on ClinicalTrials.gov