NCT03782155

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
2.4 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

October 15, 2018

Last Update Submit

September 2, 2020

Conditions

Wound HealingDiabetic

Keywords

wound healing, diabetes wound healing

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (9)

  • Bates- Jensen wound tool

    15 days

  • Biochemical serum values of CPR

    15 days

  • Biochemical serum values of creatinine

    15 days

  • +6 more other outcomes

Study Arms (2)

HMB and glutamine supplementation

EXPERIMENTAL

Patients with type 2 diabetes with supplementation HMB 3g, powder once a day and glutamine powder 14g once a day supplementation during 15 days.

Drug: glutamine supplementationDrug: HMB

placebo patients

PLACEBO COMPARATOR

Patients with type 2 diabetes with placebo( calcium caseinate) supplementation during 15 days 17g of powder once a day

Drug: Placebo

Interventions

glutamine supplementationDRUG

powder 14g

Also known as: Glutamine
HMB and glutamine supplementation
HMBDRUG

powder 3g

HMB and glutamine supplementation
PlaceboDRUG

powder 17g

Also known as: Calcic caseinate
placebo patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients with cancer or immunodeficiency
  • patients with HbA1c \< 12
  • patients with collagen disease
  • patients with allergy to intervention substances (HMB, glutamine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de México

Mexico City, Mexico

Location

Related Publications (11)

  • 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.

    PMID: 20692599BACKGROUND

  • 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.

    PMID: 27556777BACKGROUND

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

    PMID: 20130158BACKGROUND

  • Gundogdu RH, Temel H, Bozkirli BO, Ersoy E, Yazgan A, Yildirim Z. Mixture of Arginine, Glutamine, and beta-hydroxy-beta-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.

    PMID: 26826258BACKGROUND

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

    PMID: 24463351BACKGROUND

  • 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.

    PMID: 24867069BACKGROUND

  • 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. doi: 10.12968/jowc.2014.23.5.259.

    PMID: 24810310BACKGROUND

  • 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.

    PMID: 20386331BACKGROUND

  • 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.

    RESULT

  • 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. BMC Nephrol. 2013 Jan 12;14:8. doi: 10.1186/1471-2369-14-8.

    PMID: 23311725RESULT

  • 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 J Parenter Enteral Nutr. 2004 Mar-Apr;28(2):65-75. doi: 10.1177/014860710402800265.

    PMID: 15080599RESULT

MeSH Terms

Interventions

Glutamine

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Vanessa Fuchs, PhD

    Hospital General de México

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Fuchs, PhD

CONTACT

551 85331635vanessafuchs@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized clinical trial study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinical nutrition

Study Record Dates

First Submitted

October 15, 2018

First Posted

December 20, 2018

Study Start

June 1, 2021

Primary Completion

August 1, 2021

Study Completion

December 31, 2021

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

ME(1)