Status Approved
First Submitted Date
2020/01/08
Registered Date
2020/01/22
Last Updated Date
2020/01/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004641 |
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Unique Protocol ID | 2019-10-007 |
Public/Brief Title | Application of human body to confirm body fat improvement effect and safety of plant origin probiotics |
Scientific Title | Application of human body to confirm body fat improvement effect and safety of plant origin probiotics |
Acronym | LPD_DS |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | DMC-201910007003 |
Approval Date | 2019-12-23 |
Institutional Review Board Name | Daejin Medical Foundation Bundang Jaesang Hospital Hospital Bioethics Review Board |
Institutional Review Board Address | 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do |
Institutional Review Board Telephone | 031-779-5061 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Oran Kwon |
Title | Professor |
Telephone | +82-2-3277-3087 |
Affiliation | Ewha Womens University |
Address | 52, Ewhayeodae-gil, Seodaemun-gu, Seoul |
Contact Person for Public Queries | |
Name | Kyuyoung Han |
Title | Graduate student |
Telephone | +82-2-3277-3087 |
Affiliation | Ewha Womens University |
Address | 52, Ewhayeodae-gil, Seodaemun-gu, Seoul |
Contact Person for Updating Information | |
Name | Kyuyoung Han |
Title | Graduate student |
Telephone | +82-2-3277-3087 |
Affiliation | Ewha Womens University |
Address | 52, Ewhayeodae-gil, Seodaemun-gu, Seoul |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-01-20 Anticipated | |
Target Number of Participant | 88 | |
Primary Completion Date | 2020-12-22 , Anticipated | |
Study Completion Date | 2020-12-22 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Bundang Jesaeng Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-01-20 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Daesang |
Organization Type | Pharmaceutical Company |
Project ID | 2-2018-1721-001-1 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Ewha Womens University |
Organization Type | University |
7. Study Summary
Lay Summary | The purpose of this study is to evaluating effectiveness and safety of plant origin probiotics on body fat of subjects who are obese aged more than 20 years and less than 65 years old. The study was designed as 12 weeks consumption, randomized, double-blind, parallel, and placebo-control led design. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Others |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | Subject who voluntarily agree to participate and signs informed consent form at visit1(0week) are diagnosed whether they are suitable or not by inclusive and exclusive criteria. Then subjects are randomly assigned to placebo or plant origin probiotics group according to registered order. Control group takes 2 placebo capsules and test group takes 2 plant origin probiotics capsules (500mg/capsule) once for two times a day for 12 weeks and carrying out the efficacy test at each visit. |
Number of Arms | 2 |
Arm 1 |
Arm Label Experimental group |
Target Number of Participant 44 |
|
Arm Type Experimental |
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Arm Description Consumption of 2 capsules of plant origin probiotics twice a day for 12 weeks |
|
Arm 2 |
Arm Label Control group (Placebo) |
Target Number of Participant 44 |
|
Arm Type Placebo comparator |
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Arm Description Consumption of 2 placebo capsules twice a day for 12 weeks |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.0)Obesity due to excess calories Obese adults with increased fat mass due to excessive diet |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~63Year |
|
Description 1) Subject who voluntarily agree to participate and signs informed consent form 2) Aged more than 19 years and less less than 65 years, women and men 3) Those who have a body mass index (BMI) of 25kg/ bb m*2 or more and less than 30kg/m*2 4) Those who can follow the diet and exercise guidelines during the intervention period |
|
Exclusion Criteria |
1) Those who have taken or are likely to take medications that affect body weight, blood sugar, lipids, or intestinal health within one month of the first visit 2) Those who have taken antibiotics within 2 months of the first visit or are likely to take it during the study 3) If you have, 1.Uncontrolled hypertension 2. Those who have been diagnosed with diabetes or are determined to need treatment, or who have fasting blood sugar level of 180 mg / dL or more 3. Liver dysfunction or hepatobiliary disease 4. Renal dysfunction 5. Hyperthyroidism and hypofunction, Cushing's syndrome 6. If you have a medical history of severe central nervous system disorders that require hospitalization or medication 7. Those with severe cerebrovascular disease, heart disease. However, dizziness If there is no medical history, it may be excluded at the discretion of the researcher. 8. Malignant tumor, lung disease, musculoskeletal disease, immune system or inflammatory disease 9. A person who complains of gastrointestinal disorders or severe gastrointestinal symptoms such as heartburn, indigestion or severe constipation 10) Those who have continuously consumed dietary supplements or herbal medicines affecting their weight, blood sugar, and lipids within one month of their first visit. 11) Those who have consistently consumed foods,Probiotics 12) Those who have hypersensitivity to the test / control food or ingredients or have experienced severe food allergic reactions. 13) Participants in other human application research within 1 month of first visit 14) Pregnant or lactating women 15) Those who have difficulty using a smartphone or computer 16) If the researcher deems inappropriate to participate in this study |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Body fat improvement indicator |
|
Timepoint | Week 0(visit2), week 12(visit4) |
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Secondary Outcome(s) 1 | ||
Outcome | Body fat related metabolic indicators |
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Timepoint | Week 0(visit2), week 12(visit4) |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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