Pancreatobiliary Disease; Liver DiseaseNCT03201926
Development and Clinical Application of Invalid Foods Using Mealworms
A study testing mealworms and grain powder in people with Pancreatobiliary Disease; Liver Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Pancreatobiliary Disease; Liver Disease
- What is being tested?
- mealworms and grain powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jun 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Previous history of surgery affecting nutritional status
- Pregnant and lactating women
- Patients with allergy to mealworms
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
JoonSeong Park
About this study
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.
- Conditions
- Pancreatobiliary Disease; Liver Disease
- Being tested
- mealworms, grain powder
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mealwormsDietary supplement
10g , 3 times a day , po, 2 months
grain powderDietary supplement
grain powder, 10g ,3times one day,2months
| Study group | Role | What they receive |
|---|---|---|
| mealworms | Experimental | mealworms Receives: Dietary Supplement: mealworms |
| grain powder | Placebo comparator | grain powder Receives: Dietary Supplement: grain powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Body mass index
Improvement of Nutrition index ( Body cell mass, Soft lean mass, Fat free mass, Fat mass)
Measured: 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 outcomes (2)
Improvement of Body weight change
weight in kilograms, height in meters, BMI in kg/m^2
Measured: 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
Improvement of Immune parameters(T cell, INF-r, TNF-a, NK cell, IL-1, IL-2)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start26 Jun 2017
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatobiliary Disease; Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Seong Park, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201926
- Sponsor's protocol ID
- 3-2017-0077
- Status last verified
- Jan 2019
- First submitted
- 22 Jun 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32153957
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Application of Invalid Foods Using Mealworms
- ClinicalTrials.gov ID
- NCT03201926
- Acronym / sponsor ID
- 3-2017-0077
- Conditions
- Pancreatobiliary Disease; Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mealworms | Experimental | Dietary Supplement: mealwormsmealworms |
| grain powder | Placebo comparator | Dietary Supplement: grain powdergrain powder |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mealworms10g , 3 times a day , po, 2 months | Dietary supplement | mealworms |
| grain powdergrain powder, 10g ,3times one day,2months | Dietary supplement | grain powder |
Primary outcome
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)
2 secondary outcomes
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 32153957Kim 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.
Related trials for Pancreatobiliary Disease; Liver Disease
Recruiting
Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
Stage IV Esophageal Adenocarcinoma, Stage IV Esophageal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mealworms and grain powder in people with Pancreatobiliary Disease; Liver Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JoonSeong Park (02-2019-3375, JSPARK330@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.