Development and Clinical Application of Invalid Foods Using Mealworms

NCT ID: NCT03201926

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-26

Study Completion Date

2020-12-31

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.

Detailed Description

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Conditions

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Pancreatobiliary Disease; Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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mealworms

mealworms

Group Type EXPERIMENTAL

mealworms

Intervention Type DIETARY_SUPPLEMENT

10g , 3 times a day , po, 2 months

grain powder

grain powder

Group Type PLACEBO_COMPARATOR

grain powder

Intervention Type DIETARY_SUPPLEMENT

grain powder, 10g ,3times one day,2months

Interventions

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mealworms

10g , 3 times a day , po, 2 months

Intervention Type DIETARY_SUPPLEMENT

grain powder

grain powder, 10g ,3times one day,2months

Intervention Type DIETARY_SUPPLEMENT

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 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Joon Seong Park

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JoonSeong Park

Role: CONTACT

02-2019-3375

Facility Contacts

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JoonSeong Park

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32153957 (View on PubMed)

Other Identifiers

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3-2017-0077

Identifier Type: -

Identifier Source: org_study_id

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