Development and Clinical Application of Invalid Foods Using Mealworms

January 15, 2019 updated by: Joon Seong Park, Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • JoonSeong Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mealworms
Dietary supplement: mealworms
10g , 3 times a day , po, 2 months
Placebo Comparator: grain powder
Dietary supplement: grain powder
grain powder, 10g ,3times one day,2months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Body mass index
Time Frame: 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)
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
Time Frame: 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
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
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2017-0077

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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