ClinicalTrials.gg
Not yet recruitingNCT07780006Updated Aug 21, 2026

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

An interventional study of Oral nutritional supplementation in Femoral Neck Fractures, Geriatric Hip Fracture and Hip Fracture, Post Surgery Recovery, Muscle Resilience, sponsored by Thammasat University. Not yet recruiting at 1 site in Thailand. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Thammasat University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

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
02

Conditions studied

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

Keywords

  • Femoral neck fractures
  • Oral nutritional supplementation
  • HMB
03

In context

Femoral Neck Fractures

207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 142 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Femoral neck fracture patients undergoing hip arthroplasty (Total hip arthroplasty or bipolar hemiarthroplasty)
  • Age ≥ 65 years
  • (ASA) class I-III
  • Participants understand and consent to the protocol of the trial

Exclusion criteria

Exclusion Criteria:

  • Pathologic fracture or high impact fracture
  • Morbid obesity ( > 40)
  • Chronic kidney disease (Chronic kidney disease stage > 3b or estimated (eGFR) \< 30)
  • Thyroid disease or endrocrinopathy
  • Gastrointestinal intolerance preventing oral supplementation or Malabsorption syndromes
  • with radiotherapy or chemotherapy
  • Cognitive disorder
  • Decompensated Liver Disease or Cirrhosis Class B-C
  • Known allergy/intolerance to milk or other supplement ingredients
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    ONS group

    Receive oral nutritional supplement (Ensure® Plus Advance) 2 serves / day x 30 days + Standard oral intake

    Dietary Supplement: Oral nutritional supplementation

  • No intervention
    Control group

    Receive standard oral intake

Interventions

  • Dietary supplementOral 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.)

    Also known as: Ensure Advanced Plus

06

What researchers measure

Primary outcomes

  1. Hand grip strength

    Hand grip strength, assess using hand dynamometer

    Time frame: 12 weeks postoperatively

Secondary outcomes

  1. Hand grip strength

    Hand grip strength, assess using hand dynamometer

    Time frame: 2, 6 weeks postoperatively

  2. Body weight

    Time frame: 2, 6, 12 weeks postoperatively

  3. Body mass index (BMI)

    Time frame: 2, 6, 12 weeks postoperatively

  4. Serum albumin

    Time frame: 2, 6, 12 weeks postoperatively

  5. Time up and go (TUG)

    Performance-based outcome

    Time frame: 2, 6, 12 weeks postoperatively

  6. 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.

    Time frame: 2, 6, 12 weeks postoperatively

  7. Barthel index

    Index for Activities of Daily Living. Scores range from 0 to 100, with higher scores mean the person is more independent.

    Time frame: 2, 6, 12 weeks postoperatively

  8. 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.

    Time frame: 2, 6, 12 weeks postoperatively

  9. 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.

    Time frame: 2, 6, 12 weeks postoperatively

07

Study locations

1 site
08

References and documents

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 26965178 ↗
  • 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. PubMed 35615598 ↗
  • 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. PubMed 28539168 ↗
  • 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. PubMed 35911112 ↗
  • 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. PubMed 28493406 ↗
  • 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. PubMed 27108182 ↗
  • 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. PubMed 26169182 ↗
  • 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. PubMed 26529601 ↗
  • 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. PubMed 23085015 ↗
  • 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. PubMed 25082206 ↗
  • 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. PubMed 27898998 ↗
  • 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. PubMed 35306388 ↗
  • 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. PubMed 21187532 ↗
  • 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. PubMed 27180154 ↗
  • 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. PubMed 40390133 ↗
  • 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. PubMed 40869488 ↗
  • 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. PubMed 38613102 ↗
  • 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. PubMed 29710860 ↗
  • 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. PubMed 36571633 ↗
  • 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. PubMed 31775693 ↗
  • 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. PubMed 39115063 ↗
  • 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. PubMed 40220055 ↗
  • 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. PubMed 16983459 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 63 non-industry interventional studies with no phase under Femoral Neck Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 62. This study's planned 12 months is below that.

Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 25 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2026
First posted
Aug 21, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Dec 2027
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07780006
Lead sponsor
Thammasat University
Responsible party
Natthasit Wongwarawanith (Principal Investigator, Thammasat University) — Principal investigator
First posted
Aug 21, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Natthasit Wongwarawanith, MD
Contact
natthasit_fight@hotmail.com
+66868855682
Supakit Kanitnate, MD
Contact
naypeng@hotmail.com
+66899853635

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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