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Development and Clinical Application of Invalid Foods Using Mealworms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201926
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Joon Seong Park, 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.

Condition or disease Intervention/treatment Phase
Pancreatobiliary Disease; Liver Disease Dietary Supplement: mealworms Dietary Supplement: grain powder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Development and Clinical Application of Invalid Foods Using Mealworms
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: mealworms
mealworms
Dietary Supplement: mealworms
10g , 3 times a day , po, 2 months

Placebo Comparator: grain powder
grain powder
Dietary Supplement: grain powder
grain powder, 10g ,3times one day,2months




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201926


Contacts
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Contact: JoonSeong Park 02-2019-3375 JSPARK330@yuhs.ac

Locations
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Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: JoonSeong Park         
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joon Seong Park, Principal Investigator, Yonsei University
ClinicalTrials.gov Identifier: NCT03201926    
Other Study ID Numbers: 3-2017-0077
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases