NCT07780006|Not Yet RecruitingDMC
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Sponsor study identifier
interventional
60
1 country
1
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 14, 2026
Actual (reported)August 21, 2026
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Hand grip strength
Hand grip strength, assess using hand dynamometer
12 weeks postoperatively
Hand grip strength
2, 6 weeks postoperatively
Body weight
2, 6, 12 weeks postoperatively
Body mass index (BMI)
2, 6, 12 weeks postoperatively
Receive oral nutritional supplement (Ensure® Plus Advance) 2 serves / day x 30 days + Standard oral intake
Receive standard oral intake
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.)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Thammasat University
Pathum Thani, 12120, Thailand
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.
Ashkenazi 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.
First Submitted
August 14, 2026
First Posted
August 21, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
Serum albumin
2, 6, 12 weeks postoperatively
Time up and go (TUG)
2, 6, 12 weeks postoperatively
Contact the study team to confirm eligibility.
Malafarina 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.
Lin 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.
Holecek 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.
Kuriyan 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.
Wu 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.
Berton 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.
Fitschen 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.
Rizzoli 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.
Avenell 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.
Volkert 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.
Miyanishi 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.
Uriz-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.
Huang 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.
Meermans G, van Egmond JC. Malnutrition in Older Hip Fracture Patients: Prevalence, Pathophysiology, Clinical Outcomes, and Treatment-A Systematic Review. J Clin Med. 2025 Aug 11;14(16):5662. doi: 10.3390/jcm14165662.
Chiavarini M, Ricciotti GM, Genga A, Faggi MI, Rinaldi A, Toscano OD, D'Errico MM, Barbadoro P. Malnutrition-Related Health Outcomes in Older Adults with Hip Fractures: A Systematic Review and Meta-Analysis. Nutrients. 2024 Apr 5;16(7):1069. doi: 10.3390/nu16071069.
Malafarina V, Reginster JY, Cabrerizo S, Bruyere O, Kanis JA, Martinez JA, Zulet MA. Nutritional Status and Nutritional Treatment Are Related to Outcomes and Mortality in Older Adults with Hip Fracture. Nutrients. 2018 Apr 30;10(5):555. doi: 10.3390/nu10050555.
Forssten MP, Mohammad Ismail A, Ioannidis I, Wretenberg P, Borg T, Cao Y, Ribeiro MAF Jr, Mohseni S. The mortality burden of frailty in hip fracture patients: a nationwide retrospective study of cause-specific mortality. Eur J Trauma Emerg Surg. 2023 Jun;49(3):1467-1475. doi: 10.1007/s00068-022-02204-6. Epub 2022 Dec 26.
Xu BY, Yan S, Low LL, Vasanwala FF, Low SG. Predictors of poor functional outcomes and mortality in patients with hip fracture: a systematic review. BMC Musculoskelet Disord. 2019 Nov 27;20(1):568. doi: 10.1186/s12891-019-2950-0.
Kim DH, Rockwood K. Frailty in Older Adults. N Engl J Med. 2024 Aug 8;391(6):538-548. doi: 10.1056/NEJMra2301292. No abstract available.
Panait C, D'Amelio P. Advancing care: optimizing osteoporosis treatment in the older and oldest old population. Aging Clin Exp Res. 2025 Apr 12;37(1):123. doi: 10.1007/s40520-025-02973-1.
Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. doi: 10.1007/s00198-006-0172-4. Epub 2006 Sep 16.
October 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
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