Nutritional Supplements and Foot Surgery
July 30, 2023 updated by: NutraHeal
Nutritional Supplements to Support Recovery After Foot Surgery - A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- Advanced Regional Center for Ankle and Foot Care
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Ebensburg, Pennsylvania, United States, 15931
- Advanced Regional Center for Ankle & Foot Care
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State College, Pennsylvania, United States, 16801
- Advanced Regional Center for Ankle & Foot Care
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NutraHeal
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.
|
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.
|
|
Experimental: NutraHeal Plus
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).
|
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.
|
|
No Intervention: Standard of Care
Receive standard of care for 1 week prior to surgery and 3 weeks after foot surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound Healing at 3 weeks after surgery
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
|
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.
|
|
Pain Interference
Time Frame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
|
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.
|
|
Fatigue
Time Frame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
|
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.
|
|
Wound Healing at 1 week after surgery
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Disturbance
Time Frame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
|
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.
|
|
Physical Function
Time Frame: Baseline, the day of surgery, and at 1 and 3 weeks after surgery.
|
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.
|
|
Patient Satisfaction
Time Frame: 3 weeks after surgery.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lenore Moyer, DPM, Advanced Regional Center for Ankle and Foot Care
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- MacKay D, Miller AL. Nutritional support for wound healing. Altern Med Rev. 2003 Nov;8(4):359-77.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2022
Primary Completion (Actual)
March 17, 2023
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
August 18, 2022
First Submitted That Met QC Criteria
August 27, 2022
First Posted (Actual)
August 30, 2022
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 30, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NH001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.