Effect of hydrolyzed collagen alone, or in combination with fish oil on wound healing, metabolic disorders and adipose derived peptides in patients with burn

Investigating the effect of hydrolyzed collagen alone or in combination with fish oil on wound healing, metabolic disorders, and adipose derived factors in patients with burns

A randomized, double-blind, parallel design clinical trial, with two intervention groups (collagen alone and collagen plus fish oil) and a control group

In this clinical trial, patients with burn admitted to Motahari hospital will be included if they met the inclusion criteria. After obtaining a written consent, patients will be randomly divided to three groups to receive collagen alone (40 g daily), collagen plus fish oil (40 g daily plus 10 ml fish oil) and control (placebo with similar characteristics). In each group, 22 patients will receive the supplements for 4 weeks. The participants and main investigators will not be aware of the contents of the supplement and placebo. An individualized nutrition program will be provided for each patient. At the beginning, and at the end of weeks 2 and 3, a 10cc fasting blood sample will be taken. The levels of inflammatory and nutritional factors, anthropometric measurements, and clinical outcomes, including wound healing and hospitalization time, will be examined.

Inclusion criteria: Burns of 20-45% of body surface area and degree 2 (deep) or 3, age 18-60 year, and the ability to oral intake of foods. Non-inclusion criteria: History of any metabolic or chronic diseases, such as diabetes and organ failures, BMI<18.5 kg/m2, allergy or intolerance to protein products, pregnant women, and addicts.

The protein supplement of hydrolyzed collagen will be given to patients with burn alone or with fish oil that contains essential fatty acids. The control group will receive a placebo with the same characteristics.

Pre-albumin serum levels

Change in the timing of the measurement of blood parameters is due to limitations and difficulties of visiting patients due to the prevalence of Covid 19. The change in the total amount of supplements is only due to the higher purity of the components, provided for this trial, and the amount of active ingredients (hydrolyzed collagen and omega-3 fatty acids) has not been changed. Adding new secondary outcomes (FGF21, NRG4, and VSS) is thanks to receiving more funding.

For random allocation of individuals to the three groups, the permuted block randomization method will be applied, using a computer program, and the length of blocks will be considered randomly as 3, 6 or 9.

The participants in this study and the main investigator who will be involved in the conduction of the project will be blind to the content of supplement and placebo. The allocation of individuals and the provision of supplement and placebo will be carried out by a person independent of the research group.