Development and Clinical Application of Invalid Foods Using Mealworms

Not Applicable

• Conditions: Pancreatobiliary Disease; Liver Disease
• Interventions: Dietary Supplement: mealworms; Dietary Supplement: grain powder

• Registration Number: NCT03201926
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-22
• Study Start: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mealworms	mealworms	mealworms
grain powder	grain powder	grain powder

Primary Outcome Measures

Name	Time	Method
Improvement of Body mass index	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)	Improvement of Nutrition index ( Body cell mass, Soft lean mass, Fat free mass, Fat mass)

Secondary Outcome Measures

Name	Time	Method
Improvement of Immune Function Index	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)	Improvement of Immune parameters(T cell, INF-r, TNF-a, NK cell, IL-1, IL-2)
Improvement of Body weight change	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)	weight in kilograms, height in meters, BMI in kg/m\^2

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of