Clinical trial NCT05522179: Nutritional Supplements and Foot Surgery
Official title: Nutritional Supplements to Support Recovery After Foot Surgery - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Injuries and Disorders
Keywords: Nutritional supplements
Lead sponsor: NutraHeal
Sponsor class: INDUSTRY
First posted: 2022-08-30
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Over a 6 month period the investigators will enroll 45 male and female patients undergoing foot surgery. This is a prospective randomized trial and participants will be assigned to NutraHeal™ (n=15), NutraHeal Plus™ (n=15), or standard of care (n=15) for 1 week prior to surgery and 3 weeks after surgery. 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. 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). Patients randomized to standard of care will not receive any of the ingredients in NutraHeal™ or NutraHeal Plus™.

The foot surgeon will evaluate the patient for 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). Wound healing will be assessed at 1 and 3 weeks after surgery. Patients will document medication compliance (day of surgery, 1 and 3 weeks after surgery), pain medication use (baseline, on the day of surgery and at 1 and 3 weeks after surgery) and rate overall satisfaction (5-point scale (1 = excellent; 2 = good; 3 = moderate; 4 = sufficient; 5 = unsatisfactory) at 3 weeks after surgery). Patients will also complete the PROMIS-29 instrument at baseline, the day of surgery, and at 1 and 3 weeks after surgery).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \> 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)

Primary outcomes:
measure: Wound Healing at 3 weeks after surgery
timeFrame: 3 weeks after surgery.
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
measure: Pain Interference
timeFrame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
measure: Fatigue
timeFrame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
measure: Wound Healing at 1 week after surgery
timeFrame: 1 week after surgery
Other outcomes:
measure: Sleep Disturbance
timeFrame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
measure: Physical Function
timeFrame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
measure: Patient Satisfaction
timeFrame: 3 weeks after surgery.
Locations:
city: Altoona
country: United States
facility: Advanced Regional Center for Ankle and Foot Care
state: Pennsylvania
city: Ebensburg
country: United States
facility: Advanced Regional Center for Ankle & Foot Care
state: Pennsylvania
city: State College
country: United States
facility: Advanced Regional Center for Ankle & Foot Care
state: Pennsylvania
Study officials:
affiliation: Advanced Regional Center for Ankle and Foot Care
name: Lenore Moyer, DPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: MacKay D, Miller AL. Nutritional support for wound healing. Altern Med Rev. 2003 Nov;8(4):359-77.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.