Development and Clinical Application of Invalid Foods Using Mealworms

Study Overview
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Brief Summary
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Malnutrition in cancer patients continues after surgery and worsens the patient's overall health and quality of life. Previous studies reported edible insects in patients' diets increased postoperative muscle mass and weight gain. Therefore, by using nutritionally excellent mealworms for a long time, it is proved that nutritional status and survival rate are improved, leading to development of various products of edible insects.

Official Title
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Development and Clinical Application of Invalid Foods Using Mealworms

Conditions
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Pancreatobiliary Disease; Liver Disease

Intervention / Treatment
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* Dietary Supplement: mealworms
* Dietary Supplement: grain powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for surgery with pancreaticobiliary disease and liver cancer (metastatic liver cancer) Karnofsky performance status ≥ 70 Patients who can communicate without difficulty in obtaining a consent form for the test Exclusion Criteria: Patients with any of the following criteria are excluded. Patients who underwent palliative surgery Patients with uncontrolled pre-operative disease Previous history of surgery affecting nutritional status Pregnant and lactating women Patients with allergy to mealworms

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mealworms<br>mealworms | Dietary Supplement: mealworms<br>* 10g , 3 times a day , po, 2 months<br>|
| Placebo Comparator: grain powder<br>grain powder | Dietary Supplement: grain powder<br>* grain powder, 10g ,3times one day,2months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Body mass index | Improvement of Nutrition index ( Body cell mass, Soft lean mass, Fat free mass, Fat mass) | Changes from baseline nutition index at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Body weight change | weight in kilograms, height in meters, BMI in kg/m^2 | Changes from baseline Body weight at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms) | 
| Improvement of Immune Function Index | Improvement of Immune parameters(T cell, INF-r, TNF-a, NK cell, IL-1, IL-2) | Changes from baseline nutition index at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms) |