Nutritional Supplements and Foot Surgery

NCT05522179 | Completed

• 1 other identifier: NH001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective randomized trial wherein participants will be assigned to NutraHeal™, NutraHeal Plus™, or standard of care for 1 week prior to foot surgery and 3 weeks after surgery. The central hypothesis is that among patients undergoing surgery, nutritional supplements that maintain energy production, muscle structure, immune function, and response to pain will support recovery from surgery.

Conditions

Foot Injuries and Disorders

Keywords

Nutritional supplements

Outcome Measures

Primary Outcomes (1)

• Wound Healing at 3 weeks after surgery

  Wound healing (time, healing quality, erythema and new tissue quality), using a Likert rating scale against expected results from -4 (much worse) to +4 (much better) including the expected reference grade of zero (0). Positive scores are a better outcome.

  3 weeks after surgery.

Secondary Outcomes (4)

• Pain Intensity

  Baseline, the day of surgery, and at 1 and 3 weeks after surgery.

• Pain Interference

  Baseline, the day of surgery, and at 1 and 3 weeks after surgery.

• Fatigue

  Baseline, the day of surgery, and at 1 and 3 weeks after surgery.

• Wound Healing at 1 week after surgery

  1 week after surgery

Other Outcomes (3)

• Sleep Disturbance

  Baseline, the day of surgery, and at 1 and 3 weeks after surgery.

• Physical Function

  Baseline, the day of surgery, and at 1 and 3 weeks after surgery.

• Patient Satisfaction

  3 weeks after surgery.

Study Arms (3)

NutraHeal

EXPERIMENTAL

NutraHeal™ is a nutritional supplement that contains 7.5 micrograms (300 IU) of Vitamin D3, 80 mg of Calcium as Calcium Hydroxymethylbutyrate Monohydrate, 7.5 mg of Zinc, 600 mg of Calcium Hydroxymethylbutyrate Monohydrate, and 45 mg of Bromelain.

Dietary Supplement: NutraHeal

NutraHeal Plus

EXPERIMENTAL

NutraHeal Plus™ is a nutritional supplement that contains 80 mg of Calcium as Calcium Hydroxymethylbutyrate Monohydrate, 7.5 mg of Zinc, 600 mg of Calcium Hydroxymethylbutyrate Monohydrate, 45 mg of Bromelain, and 7.5 mg of reduced Nicotinamide Adenine Dinucleotide (NADH).

Dietary Supplement: NutraHeal Plus

Standard of Care

NO INTERVENTION

Receive standard of care for 1 week prior to surgery and 3 weeks after foot surgery.

Interventions

NutraHeal DIETARY_SUPPLEMENT

Receive NutraHeal (2 capsules twice a day) as a dietary supplement beginning 1 week prior to surgery and extending to 3 weeks after foot surgery.

NutraHeal

NutraHeal Plus DIETARY_SUPPLEMENT

Receive NutraHeal Plus (2 capsules twice a day) as a dietary supplement beginning 1 week prior to surgery and extending to 3 weeks after foot surgery.

NutraHeal Plus

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 20 years of age
• Undergoing foot surgery (matrixectomy (ingrown toenail removal) and wart removal)

You may not qualify if:

• \> 80 years of age
• Pregnant patients or those anticipating pregnancy in the 1 month study period
• Allergic to pineapple
• Treated with oral anticoagulation
• Currently receiving Bromelain, Hydroxymethylbutyrate Monohydrate (HMB), reduced Nicotinamide Adenine Dinucleotide (NADH), Vitamin D3, or Zinc.
• Alcoholism (\>2 drinks/day)
• Insulin Dependent Diabetes
• Hepatic insufficiency (prior known liver function tests \> 1.5 times the upper limit of normal)
• Renal failure (prior known creatinine \> 2.0 mg/dl)
• Severe pulmonary disease (requiring home oxygen therapy)
• Psychiatric illness requiring therapy (DSM-V thought disorders, recurrent major depressive disorder)

Sponsors & Collaborators

• NutraHeal: lead

Study Sites (3)

Advanced Regional Center for Ankle and Foot Care

Altoona, Pennsylvania, 16602, United States

Location

Advanced Regional Center for Ankle & Foot Care

Ebensburg, Pennsylvania, 15931, United States

Location

Advanced Regional Center for Ankle & Foot Care

State College, Pennsylvania, 16801, United States

Location

Related Publications (14)

• Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.

  PMID: 29369092 BACKGROUND

• Gillis C, Wischmeyer PE. Pre-operative nutrition and the elective surgical patient: why, how and what? Anaesthesia. 2019 Jan;74 Suppl 1:27-35. doi: 10.1111/anae.14506.

  PMID: 30604414 BACKGROUND

• Paddon-Jones D, Campbell WW, Jacques PF, Kritchevsky SB, Moore LL, Rodriguez NR, van Loon LJ. Protein and healthy aging. Am J Clin Nutr. 2015 Jun;101(6):1339S-1345S. doi: 10.3945/ajcn.114.084061. Epub 2015 Apr 29.

  PMID: 25926511 BACKGROUND

• MacKay D, Miller AL. Nutritional support for wound healing. Altern Med Rev. 2003 Nov;8(4):359-77.

  PMID: 14653765 BACKGROUND

• Brien S, Lewith G, Walker A, Hicks SM, Middleton D. Bromelain as a Treatment for Osteoarthritis: a Review of Clinical Studies. Evid Based Complement Alternat Med. 2004 Dec;1(3):251-257. doi: 10.1093/ecam/neh035. Epub 2004 Oct 6.

  PMID: 15841258 BACKGROUND

• Howat RC, Lewis GD. The effect of bromelain therapy on episiotomy wounds--a double blind controlled clinical trial. J Obstet Gynaecol Br Commonw. 1972 Oct;79(10):951-3. doi: 10.1111/j.1471-0528.1972.tb12194.x. No abstract available.

  PMID: 4563795 BACKGROUND

• Landi F, Calvani R, Picca A, Marzetti E. Beta-hydroxy-beta-methylbutyrate and sarcopenia: from biological plausibility to clinical evidence. Curr Opin Clin Nutr Metab Care. 2019 Jan;22(1):37-43. doi: 10.1097/MCO.0000000000000524.

  PMID: 30489401 BACKGROUND

• 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.

  PMID: 26965178 BACKGROUND

• Lautrup S, Sinclair DA, Mattson MP, Fang EF. NAD+ in Brain Aging and Neurodegenerative Disorders. Cell Metab. 2019 Oct 1;30(4):630-655. doi: 10.1016/j.cmet.2019.09.001.

  PMID: 31577933 BACKGROUND

• Yoshino M, Yoshino J, Kayser BD, Patti GJ, Franczyk MP, Mills KF, Sindelar M, Pietka T, Patterson BW, Imai SI, Klein S. Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women. Science. 2021 Jun 11;372(6547):1224-1229. doi: 10.1126/science.abe9985. Epub 2021 Apr 22.

  PMID: 33888596 BACKGROUND

• Iglar PJ, Hogan KJ. Vitamin D status and surgical outcomes: a systematic review. Patient Saf Surg. 2015 Apr 30;9:14. doi: 10.1186/s13037-015-0060-y. eCollection 2015.

  PMID: 25926889 BACKGROUND

• Krasowska K, Skrobot W, Liedtke E, Sawicki P, Flis DJ, Dzik KP, Libionka W, Kloc W, Kaczor JJ. The Preoperative Supplementation With Vitamin D Attenuated Pain Intensity and Reduced the Level of Pro-inflammatory Markers in Patients After Posterior Lumbar Interbody Fusion. Front Pharmacol. 2019 May 22;10:527. doi: 10.3389/fphar.2019.00527. eCollection 2019.

  PMID: 31191300 BACKGROUND

• Bonaventura P, Benedetti G, Albarede F, Miossec P. Zinc and its role in immunity and inflammation. Autoimmun Rev. 2015 Apr;14(4):277-85. doi: 10.1016/j.autrev.2014.11.008. Epub 2014 Nov 24.

  PMID: 25462582 BACKGROUND

• Lin PH, Sermersheim M, Li H, Lee PHU, Steinberg SM, Ma J. Zinc in Wound Healing Modulation. Nutrients. 2017 Dec 24;10(1):16. doi: 10.3390/nu10010016.

  PMID: 29295546 BACKGROUND

MeSH Terms

Conditions

Foot Injuries; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lenore Moyer, DPM

  Advanced Regional Center for Ankle and Foot Care

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 30, 2022
• Study Start: August 29, 2022
• Primary Completion: March 17, 2023
• Study Completion: July 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)