Back to resultsDevelopment and Clinical Application of Invalid Foods Using Mealworms
Primary Purpose
Pancreatobiliary Disease; Liver Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mealworms
grain powder
Sponsored by
About this trial
This is an interventional other trial for Pancreatobiliary Disease; Liver Disease
Eligibility 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
Sites / Locations
- Gangnam Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
mealworms
grain powder
Arm Description
mealworms
grain powder
Outcomes
Primary Outcome Measures
Improvement of Body mass index
Improvement of Nutrition index ( Body cell mass, Soft lean mass, Fat free mass, Fat mass)
Secondary Outcome Measures
Improvement of Body weight change
weight in kilograms, height in meters, BMI in kg/m^2
Improvement of Immune Function Index
Improvement of Immune parameters(T cell, INF-r, TNF-a, NK cell, IL-1, IL-2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03201926
Brief Title
Development and Clinical Application of Invalid Foods Using Mealworms
Official Title
Development and Clinical Application of Invalid Foods Using Mealworms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatobiliary Disease; Liver Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mealworms
Arm Type
Experimental
Arm Description
mealworms
Arm Title
grain powder
Arm Type
Placebo Comparator
Arm Description
grain powder
Intervention Type
Dietary Supplement
Intervention Name(s)
mealworms
Intervention Description
10g , 3 times a day , po, 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
grain powder
Intervention Description
grain powder, 10g ,3times one day,2months
Primary Outcome Measure Information:
Title
Improvement of Body mass index
Description
Improvement of Nutrition index ( Body cell mass, Soft lean mass, Fat free mass, Fat mass)
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)
Secondary Outcome Measure Information:
Title
Improvement of Body weight change
Description
weight in kilograms, height in meters, BMI in kg/m^2
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)
Title
Improvement of Immune Function Index
Description
Improvement of Immune parameters(T cell, INF-r, TNF-a, NK cell, IL-1, IL-2)
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JoonSeong Park
Phone
02-2019-3375
Email
JSPARK330@yuhs.ac
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JoonSeong Park
12. IPD Sharing Statement
Citations:
PubMed Identifier
32153957
Citation
Kim HS, Lee YS, Jang SY, Jun SY, Lim JH, Kim IK, Kim HM, Park JS. 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. BMC Nutr. 2019 Nov 18;5:44. doi: 10.1186/s40795-019-0307-6. eCollection 2019.
Results Reference
derived
Learn more about this trial
Development and Clinical Application of Invalid Foods Using Mealworms
We'll reach out to this number within 24 hrs