NCT05532488

Inulin in Burn-induced Insulin Resistance

The Inulin Effect on Burn-induced Insulin Resistance: a Randomized, Double-blind Placebo-controlled Pilot Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Belgrade · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this clinical trial, investigators will test the effects of dietary supplement inulin, on the reduction of insulin resistance developed as a result of burn injuryy.

Detailed description

As a consequence of burn injury, an exaggerated inflammatory response is developing in parallel with metabolic changes, which led to the development of hyperglycemia and insulin resistance. The post burn-injury insulin resistance is different in comparison to other trauma-induced insulin resistance. The main difference is the length. More precisely postburn-injury insulin resistance lasts longer than insulin resistance developed after other traumas. Insulin resistance can persist for years after the burn heals. Inulin is a heterogeneous mixture of fructose polymers that are widely distributed in nature as storage of carbohydrates in plants. This mixture of fructose has nutritional value, but also affects general health, reducing the risk of developing various diseases. Inulin prevents gastrointestinal complications such as constipation, increases the resorption of minerals from the gastrointestinal tract, stimulates the immune system, and functions as a prebiotic, but can also affect insulin resistance in patients with metabolic syndrome. The hypothesis: The everyday inulin can affect postburn-injury insulin resistance. To investigate the effect of inulin on patients with postburn-injury insulin resistance a prospective, double-blind, randomized, and placebo-controlled clinical trial will be performed. This initial trial is a pilot trial. The pilot trial will be performed to assess the safety of treatment or interventions and recruitment potentials, examine the randomization and blinding process, increase the researchers' experience with the study methods and interventions, and provide estimates for sample size calculation for the main study.

Conditions

• Burn Injury
• Insulin Resistance
• Post Burn Insulin Resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Inulin 20 mg	Inulin can increase gut Bifidobacterium count. Bifidobacterium has beneficial effects on the metabolic profile and insulin resistance biomarkers.
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2022-09-08
• Last updated: 2024-04-26

Locations

1 site across 1 country: Serbia