Nutritional Supplements and Foot Surgery

Foot Injuries and Disorders Clinical Trial

Official title:

Nutritional Supplements to Support Recovery After Foot Surgery - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05522179
• Other study ID #: NH001
• Status: Completed
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: July 2023
• Source: NutraHeal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 30, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Foot Injuries
• Foot Injuries and Disorders

Intervention

Dietary Supplement:
• NutraHeal
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 Plus
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.

Locations

Country	Name	City	State
United States	Advanced Regional Center for Ankle and Foot Care	Altoona	Pennsylvania
United States	Advanced Regional Center for Ankle & Foot Care	Ebensburg	Pennsylvania
United States	Advanced Regional Center for Ankle & Foot Care	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
NutraHeal

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

MacKay D, Miller AL. Nutritional support for wound healing. Altern Med Rev. 2003 Nov;8(4):359-77. — View 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. — View 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. Erratum In: Anesth Analg. 2018 Nov;127(5):e95. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Disturbance	Sleep disturbance over previous 7 days as recorded in PROMIS-29. Sleep quality is assessed on a scale of 1-5 (1 = very good, 2 = good, 3= fair, 4 = poor, 5 = very poor). Higher scores indicate a worse outcome.	Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
Other	Physical Function	Physical function as recorded in PROMIS-29. Physical function is assessed on a scale of 1-5 (1 = without any difficulty, 2 = with a little difficulty, 3= with some difficulty, 4 = with much difficulty, 5 = unable to do). Higher scores indicate a worse outcome.	Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
Other	Patient Satisfaction	Overall satisfaction with 1) use of the nutritional supplements and 2) wound healing. Satisfaction is assessed on a scale of 1-5 (1 = excellent, 2 = good, 3 = moderate, 4 = sufficient, 5 = unsatisfactory). Higher scores indicate a worse outcome.	3 weeks after surgery.
Primary	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	Pain Intensity	Average pain intensity over previous 7 days as recorded in PROMIS-29. Pain intensity is graded on a visual analog scale from 0 (no pain) to 10 (worst imaginable pain). Higher scores mean a worse outcome.	Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
Secondary	Pain Interference	Average pain interference over previous 7 days as recorded in PROMIS-29. Pain interference is graded on a scale of 1-5 (1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, 5 = Very much). Higher scores mean a worse outcome.	Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
Secondary	Fatigue	Fatigue over previous 7 days as recorded in PROMIS-29. Fatigue is graded on a scale of 1-5 (1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, 5 = Very much). Higher scores mean a worse outcome.	Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
Secondary	Wound Healing at 1 week 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.	1 week after surgery