Femoral Neck FracturesNCT07780006
Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty
A study testing Oral nutritional supplementation in people with Femoral Neck Fractures and Geriatric Hip Fracture, run by Thammasat University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Neck Fractures, Geriatric Hip Fracture, Hip Fracture, Post Surgery Recovery, Muscle Resilience
- What is being tested?
- Oral nutritional supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Femoral neck fracture patients undergoing hip arthroplasty (Total hip arthroplasty or bipolar hemiarthroplasty)
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) class I-III
- Participants understand and consent to the protocol of the trial
Who cannot join
- Pathologic fracture or high impact fracture
- Morbid obesity (Body mass index > 40)
- Chronic kidney disease (Chronic kidney disease stage > 3b or estimated glomerular filtration rate (eGFR) < 30)
- Thyroid disease or endrocrinopathy
- Gastrointestinal intolerance preventing oral supplementation or Malabsorption syndromes
- Malignancy with radiotherapy or chemotherapy
Show all 9Show fewer
- Cognitive disorder
- Decompensated Liver Disease or Cirrhosis Child-Pugh Class B-C
- Known allergy/intolerance to milk or other supplement ingredients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Thammasat University
Pathum Thani, 12120
Department of Orthopaedics, Thammasat University, +669269775, orthotunited@orthothamma.com
About this study
Official title: Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty: A Randomized Controlled Trial
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
Read more
- 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
- Being tested
- Oral nutritional supplementation
- Keywords
- Femoral neck fractures, Oral nutritional supplementation, HMB
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplementationDietary supplement
Also called Ensure Advanced Plus
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.)
| Study group | Role | What they receive |
|---|---|---|
| ONS group | Experimental | Receive oral nutritional supplement (Ensure® Plus Advance) 2 serves / day x 30 days + Standard oral intake Receives: Dietary Supplement: Oral nutritional supplementation |
| Control group | No intervention | Receive standard oral intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Hand grip strength, assess using hand dynamometer
Measured: 12 weeks postoperatively
Secondary outcomes (9)
Hand grip strength
Hand grip strength, assess using hand dynamometer
Measured: 2, 6 weeks postoperatively
Body weight
Measured: 2, 6, 12 weeks postoperatively
Body mass index (BMI)
Measured: 2, 6, 12 weeks postoperatively
Serum albumin
Measured: 2, 6, 12 weeks postoperatively
Time up and go (TUG)
Performance-based outcome
Measured: 2, 6, 12 weeks postoperatively
Oxford hip score (OHS)
Patient-reported outcomes measurement of the hip function. Scores range from 0 to 48. Higher scores mean greater hip function and less pain.
Measured: 2, 6, 12 weeks postoperatively
Barthel index
Index for Activities of Daily Living. Scores range from 0 to 100, with higher scores mean the person is more independent.
Measured: 2, 6, 12 weeks postoperatively
Mini Nutritional Assessment (MNA)
Validated tool for assessment of elderly nutritional status. Scores range from 0 to 30. The higher scores mean normal nutritional status of the participants.
Measured: 2, 6, 12 weeks postoperatively
Geriatric Nutritional Risk Index (GNRI)
A tool used to evaluate nutritional risk, morbidity, and mortality in older adults. Scores are calculated from serum albumin and body weight of the participants (No range). Higher scores means low risk of malnutrition.
Measured: 2, 6, 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natthasit Wongwarawanith, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780006
- Sponsor's protocol ID
- Ensure_Plus
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ekinci O, Yanik S, Terzioglu Bebitoglu B, Yilmaz Akyuz E, Dokuyucu A, Erdem S. Effect of Calcium beta-Hydroxy-beta-Methylbutyrate (CaHMB), Vitamin D, and Protein Supplementation on Postoperative Immobilization in Malnourished Older Adult Patients With Hip Fracture: A Randomized Controlled Study. Nutr Clin Pract. 2016 Dec;31(6):829-835. doi: 10.1177/0884533616629628. Epub 2016 Jul 9.
PubMed 26965178Ashkenazi I, Rotman D, Amzalleg N, Graif N, Amal Khoury, Ben-Tov T, Steinberg E. Efficacy of Oral Nutritional Supplements in Patients Undergoing Surgical Intervention for Hip Fracture. Geriatr Orthop Surg Rehabil. 2022 May 20;13:21514593221102252. doi: 10.1177/21514593221102252. eCollection 2022.
PubMed 35615598Malafarina V, Uriz-Otano F, Malafarina C, Martinez JA, Zulet MA. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial. Maturitas. 2017 Jul;101:42-50. doi: 10.1016/j.maturitas.2017.04.010. Epub 2017 Apr 22.
PubMed 28539168Lin Z, Zhao A, He J. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on the Muscle Strength in the Elderly Population: A Meta-Analysis. Front Nutr. 2022 Jul 13;9:914866. doi: 10.3389/fnut.2022.914866. eCollection 2022.
PubMed 35911112Holecek M. Beta-hydroxy-beta-methylbutyrate supplementation and skeletal muscle in healthy and muscle-wasting conditions. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):529-541. doi: 10.1002/jcsm.12208. Epub 2017 May 10.
PubMed 28493406Kuriyan R, Lokesh DP, Selvam S, Jayakumar J, Philip MG, Shreeram S, Kurpad AV. The relationship of endogenous plasma concentrations of beta-Hydroxy beta-Methyl Butyrate (HMB) to age and total appendicular lean mass in humans. Exp Gerontol. 2016 Aug;81:13-8. doi: 10.1016/j.exger.2016.04.013. Epub 2016 Apr 20.
PubMed 27108182Wu H, Xia Y, Jiang J, Du H, Guo X, Liu X, Li C, Huang G, Niu K. Effect of beta-hydroxy-beta-methylbutyrate supplementation on muscle loss in older adults: a systematic review and meta-analysis. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):168-75. doi: 10.1016/j.archger.2015.06.020. Epub 2015 Jul 3.
PubMed 26169182Berton L, Bano G, Carraro S, Veronese N, Pizzato S, Bolzetta F, De Rui M, Valmorbida E, De Ronch I, Perissinotto E, Coin A, Manzato E, Sergi G. Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial. PLoS One. 2015 Nov 3;10(11):e0141757. doi: 10.1371/journal.pone.0141757. eCollection 2015.
PubMed 26529601Fitschen PJ, Wilson GJ, Wilson JM, Wilund KR. Efficacy of beta-hydroxy-beta-methylbutyrate supplementation in elderly and clinical populations. Nutrition. 2013 Jan;29(1):29-36. doi: 10.1016/j.nut.2012.05.005. Epub 2012 Oct 22.
PubMed 23085015Rizzoli R, Stevenson JC, Bauer JM, van Loon LJ, Walrand S, Kanis JA, Cooper C, Brandi ML, Diez-Perez A, Reginster JY; ESCEO Task Force. The role of dietary protein and vitamin D in maintaining musculoskeletal health in postmenopausal women: a consensus statement from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Maturitas. 2014 Sep;79(1):122-32. doi: 10.1016/j.maturitas.2014.07.005. Epub 2014 Jul 17.
PubMed 25082206Avenell A, Smith TO, Curtain JP, Mak JC, Myint PK. Nutritional supplementation for hip fracture aftercare in older people. Cochrane Database Syst Rev. 2016 Nov 30;11(11):CD001880. doi: 10.1002/14651858.CD001880.pub6.
PubMed 27898998Volkert D, Beck AM, Cederholm T, Cruz-Jentoft A, Hooper L, Kiesswetter E, Maggio M, Raynaud-Simon A, Sieber C, Sobotka L, van Asselt D, Wirth R, Bischoff SC. ESPEN practical guideline: Clinical nutrition and hydration in geriatrics. Clin Nutr. 2022 Apr;41(4):958-989. doi: 10.1016/j.clnu.2022.01.024. Epub 2022 Mar 5.
PubMed 35306388Miyanishi K, Jingushi S, Torisu T. Mortality after hip fracture in Japan: the role of nutritional status. J Orthop Surg (Hong Kong). 2010 Dec;18(3):265-70. doi: 10.1177/230949901001800301.
PubMed 21187532Uriz-Otano F, Pla-Vidal J, Tiberio-Lopez G, Malafarina V. Factors associated to institutionalization and mortality over three years, in elderly people with a hip fracture-An observational study. Maturitas. 2016 Jul;89:9-15. doi: 10.1016/j.maturitas.2016.04.005. Epub 2016 Apr 8.
PubMed 27180154Huang H, Liu Y, Zhang BF. Elevated albumin: a protective factor against mortality in geriatric hip fracture patients. J Orthop Surg Res. 2025 May 19;20(1):485. doi: 10.1186/s13018-025-05873-2.
PubMed 40390133