Trial | NCT03782155  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
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.
Study Started
Jun 01
2021
Anticipated
Primary Completion
Aug 01
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Sep 03
2020

Drug glutamine supplementation

powder 14g

  • Other names: Glutamine

Drug HMB

powder 3g

Drug Placebo

powder 17g

  • Other names: Calcic caseinate

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.

placebo patients Placebo Comparator

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

Criteria 

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)
No Results Posted