Effect of Supplementation With HMB and Glutamine in Wound Healing on Bloody Areas

Wound Healing Clinical Trial

Official title:

Effect of Supplementation With b- Hydroxy Methyl Butyrate and Glutamine in Wound Healing Histology in Type 2 Diabetes and Controls Bloody Areas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03782155
• Other study ID #: DI/17/111/03/014
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: Hospital General de Mexico
• Contact: Vanessa Fuchs, PhD
• Phone: 551 85331635
• Email: vanessafuchs[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled clinical trial in two groups of supplementation with HMB and glutamine. Each group consist in 25 patients with bloody areas, one group will receive and intervention with HMB and Glutamine and the other will receive a placebo with calcium caseinate.

Description:

A fundamental part of the integral management of wound healing in patients with bloody areas is nutrition, since it involves biochemical events that depend on the substrates it provides. Wound healing is a phase that demands higher needs of energy-protein than the requirement. Problem statement: Poor nutrition decreases, through specific phases, normal processes that allow the progression of wound healing. Nutrient deficiencies can have negative effects on wound healing by prolonging the inflammatory phase, decreasing fibroblast proliferation, and modifying collagen synthesis. Some amino acids are essential for the process, such as Glutamine and Hydroxymethylbutyrate.

Objective: To evaluate the effect of Glutamine and Hydroxymethylbutyrate supplementation over the cells involved in wound healing of bloody areas. Hypothesis: Glutamine and Hydroxymethylbutyrate supplementation promotes a positive effect over the cells involved in wound healing of bloody areas. Methodology: A randomized controlled clinical trial, in patients with diagnosis of bloody areas. They will be divided into two groups, the first will receive an intervention with Glutamine (14g) and Hydroxymethylbutyrate (3g) and a control group will receive a placebo with calcium caseinate (17g)

A sample of the affected tissue will be taken before and after the supplementation where histology will be analyzed.

Remains of tissue will be obteined during surgery wash for histology.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with bloody areas at hospital admission

• Hospital length stay around 15 days

• Medical treatment with surgical washing and negative pressure systems

• For the groups with diabetes, patients with diagnosis of type 2 diabetes with bloody areas.

• Patients that accepts and signs the informative consent.

Exclusion Criteria:

• patients with cancer or immunodeficiency

• patients with HbA1c < 12

• patients with collagen disease

• patients with allergy to intervention substances (HMB, glutamine)

Related Conditions & MeSH terms

• Diabetic
• Wound Healing
• Wounds and Injuries

Intervention

Drug:
• glutamine supplementation
powder 14g
• HMB
powder 3g
• Placebo
powder 17g

Locations

Country	Name	City	State
Mexico	Hospital General de México	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

Armstrong DG, Hanft JR, Driver VR, Smith AP, Lazaro-Martinez JL, Reyzelman AM, Furst GJ, Vayser DJ, Cervantes HL, Snyder RJ, Moore MF, May PE, Nelson JL, Baggs GE, Voss AC; Diabetic Foot Nutrition Study Group. Effect of oral nutritional supplementation on wound healing in diabetic foot ulcers: a prospective randomized controlled trial. Diabet Med. 2014 Sep;31(9):1069-77. doi: 10.1111/dme.12509. Epub 2014 Jun 19. — View Citation

Bozkirli BO, Gündogdu RH, Ersoy E, Lortlar N, Yildirim Z, Temel H, Oduncu M, Karakaya J. Pilot Experimental Study on the Effect of Arginine, Glutamine, and ß-Hydroxy ß-Methylbutyrate on Secondary Wound Healing. JPEN J Parenter Enteral Nutr. 2015 Jul;39(5):591-7. doi: 10.1177/0148607113520433. Epub 2014 Jan 24. — View Citation

Gündogdu RH, Temel H, Bozkirli BO, Ersoy E, Yazgan A, Yildirim Z. Mixture of Arginine, Glutamine, and ß-hydroxy-ß-methyl Butyrate Enhances the Healing of Ischemic Wounds in Rats. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):1045-1050. doi: 10.1177/0148607115625221. Epub 2016 Jan 29. — View Citation

Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R. Bates-Jensen wound assessment tool: pictorial guide validation project. J Wound Ostomy Continence Nurs. 2010 May-Jun;37(3):253-9. doi: 10.1097/WON.0b013e3181d73aab. — View Citation

Molnar JA, Vlad LG, Gumus T. Nutrition and Chronic Wounds: Improving Clinical Outcomes. Plast Reconstr Surg. 2016 Sep;138(3 Suppl):71S-81S. doi: 10.1097/PRS.0000000000002676. Review. — View Citation

Rathmacher JA, Nissen S, Panton L, Clark RH, Eubanks May P, Barber AE, D'Olimpio J, Abumrad NN. Supplementation with a combination of beta-hydroxy-beta-methylbutyrate (HMB), arginine, and glutamine is safe and could improve hematological parameters. JPEN — View Citation

Salas-Gonzalez P, Sevilla- Gonzalez M de la L, Fuchs- Tarlovsky V. Effect of supplementation with glutamine and hydroxymethylbutirate over the cellsinvolved un wound healing. Int J Adv Res. 2018 Aug 31;6(8):100-6.

Sipahi S, Gungor O, Gunduz M, Cilci M, Demirci MC, Tamer A. The effect of oral supplementation with a combination of beta-hydroxy-beta-methylbutyrate, arginine and glutamine on wound healing: a retrospective analysis of diabetic haemodialysis patients. BM — View Citation

Stechmiller JK. Understanding the role of nutrition and wound healing. Nutr Clin Pract. 2010 Feb;25(1):61-8. doi: 10.1177/0884533609358997. Review. — View Citation

Wild T, Rahbarnia A, Kellner M, Sobotka L, Eberlein T. Basics in nutrition and wound healing. Nutrition. 2010 Sep;26(9):862-6. doi: 10.1016/j.nut.2010.05.008. Review. — View Citation

Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bates- Jensen wound tool	To compared Bates- Jensen questionnaire will be applied two evaluations: first will be done before supplementation and second after finished the supplementation this scale consider physical characteristics of wound and give a punctuation 1 to 5 in each item ( size, depht, borders, necrosis, percentage of necrotic tissue , type of exudate, amount of exudate, skin color, edema, induration, granular tissue,epithelialization) according to this, items have a value that will be considered in a total punctuation of wound Punctuation 1-12 Health tissue 13- 59 regeneration 60. Degeneration	15 days
Other	Biochemical serum values of CPR	To evaluate and compared the values of serum CPR, two different serum samples ( at the beginning and after finished the supplementation)	15 days
Other	Biochemical serum values of creatinine	To evaluate and compared the values of serum creatinine, two different serum samples ( at the beginning and after finished the supplementation)	15 days
Other	Biochemical serum values of procalcitonine	To evaluate and compared the values of serum procalcitonine, two different serum samples ( at the beginning and after finished the supplementation)	15 days
Other	Bacterial growth per clauster in culture wound	It will be taken a bacterial culture of wound in two different moments ( at the beginning and after finished the supplementation) Will be counted the colony number per clauster and type of bacteria.	15 days
Other	Type of bacterial growth in wound	It will be taken a bacterial culture of wound in two different moments ( at the beginning and after finished the supplementation) will be counted the kind of bacteria.	15 days
Other	Glucemic control by glucose	Glucose control will be messured in serum sample (mg/dL) in two different moments: at the begining and after finished the supplementation.	15 days
Other	Glucemic control by HbA1c	HbA1c(%) control will be messured in serum in two different moments: at the begining and after finished the supplementation.	15 days
Other	Incidence of treatment- adverse events	Each day of supplementation will be performed a questionary about subjective syntoms( as abdominal pain, diarrhea, nausea, vomiting, constipation or others) of supplementation,	15 days
Primary	Wound healing:Number of cells per clauster in tissue sample of wound.	To evaluate the effect of supplementation in cellular differentiation. It will be counted and compared the number of cells per cluster in a tissue sample (lymphocytes, fibroblasts , macrophages and angiogeny) at the begining and after the supplementation.	15 days