Clinical Trials Directory

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UnknownNCT03782155

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Hospital General de Mexico · Other Government
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGglutamine supplementationpowder 14g
DRUGHMBpowder 3g
DRUGPlacebopowder 17g

Timeline

Start date
2021-06-01
Primary completion
2021-08-01
Completion
2021-12-31
First posted
2018-12-20
Last updated
2020-09-03

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT03782155. Inclusion in this directory is not an endorsement.