Clinical application of invalid foods using mealworms and evaluation of nutrition status and immune function: a study protocol for a randomized, double blind, placebo-controlled trial

BACKGROUND: Protein intake is important for the recovery of the immune system, physical strength, and wound healing after surgery. Sarcopenia is associated with a poor prognosis when compared to patients without sarcopenia in cancer patients. Recently, edible insects, such as mealworms, have been recognized as having a high protein content. In this study, we will evaluate the effect of nutritional status and immune function change based on a patient’s ingestion of mealworms after hepatobiliary pancreatic surgery. METHODS/DESIGN: This is a prospective, two-armed, phase III study investigating the effect of mealworm improving nutrition and immune status in patients after hepatobiliary pancreatic surgery. In the trial group, the patients will be provided with mealworms for 2 months after surgery. In the control group, patients will be provided with grain powder for 2 months after surgery. The target for accrual is 168 patients. We divided in to three groups according to the type of surgery. DISCUSSION: The primary endpoint is to evaluate body cell mass index 2 months postoperatively. Secondary endpoints include other body composition changes as well as nutrition index and immune function change. We expect that ingestion of mealworms can effectively improve the nutritional status and enhance the immune function. Mealworm can be used effectively for nutritional management of patients after surgery. TRIAL REGISTRATION: Clinicaltrials.gov NCT03201926 Registered June 28, 2017, retrospectively registered.