UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052740 |
|---|---|
| Receipt number | R000050232 |
| Scientific Title | Safety study for overdose of galloylated catechins - A randomized double-blind placebo controlled trial |
| Date of disclosure of the study information | 2023/11/09 |
| Last modified on | 2023/11/09 11:34:16 |
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Basic information
Public title
Safety study for overdose of galloylated catechins - A randomized double-blind placebo controlled trial
Acronym
Safety study for overdose of galloylated catechins
Scientific Title
Safety study for overdose of galloylated catechins - A randomized double-blind placebo controlled trial
Scientific Title:Acronym
Safety study for overdose of galloylated catechins - A randomized double-blind placebo controlled trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of overdose of galloylated catechins-containing supplements.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
(1)Medical interview
(2)Body weight and BMI
(3)Vital signs (systolic and diastolic blood pressure, pulse rate)
(4)Hematological parameters (white blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, platelet count, WBC fractions)
(5)Blood biochemical parameters (total protein, albumin, AST (GOT), ALT (GPT), LD (LDH), total bilirubin, ALP, gamma-GT (gamma-GTP), CK (CPK), urea nitrogen (UN), creatinine, uric acid (UA), sodium (Na), chloride (Cl), potassium (K), calcium (Ca), total cholesterol, LDL-cholesterol, HDL-cholesterol, TG(neutral fats), inorganic phosphate, magnesium (Mg), serum iron, fasting blood glucose, HbA1c)
(6)Urinalysis (protein qualitative, glucose qualitative, bilirubin qualitative, ketone bodies, urobilinogen qualitative, urinary occult blood, pH, specific gravity)
(7)Adverse events.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The galloylated catechins-containing supplements are taken 3 times a day after each meal for 4 weeks
Interventions/Control_2
The placebo supplements are taken 3 times a day after each meal for 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Age is between 20 to < 65 years old on the date of consent
(2)LDL-cholesterol level is 159 mg/dL or less, and BMI is < 30
Key exclusion criteria
(1) Current history of serious complications, and suffering from an illness that requires urgent treatment
(2)Regular intake of medication for the treatment of chronic illness (3)History of gastrointestinal diseases or surgery that affects digestion and absorption
(4)History of drug and/or alcohol addiction
(5)Potential to develop allergies against the test food
(6)Impossibility to stop the intake of health-promoting foods or quasi-drugs related to lipid metabolism
(7)Pregnancy, or desire to become pregnant, currently lactating
(8)Diagnosis of familial hyperlipidemia
(9)Currently participating in or willing to participate in other clinical studies that take other foods, use medicines, apply cosmetics and drugs, etc.
(10)Deemed ineligible to participate by the principal investigator for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
https://mol.medicalonline.jp/archive/search?jo=ef4oyoya&ye=2022&vo=103&issue=1%2F2
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
ITO EN, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人財団健康睡眠会 日本橋循環器科クリニック
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
https://mol.medicalonline.jp/archive/search?jo=ef4oyoya&ye=2022&vo=103&issue=1%2F2
Publication of results
Published
Result
URL related to results and publications
https://www.jshs.or.jp/books/jornal.html
Number of participants that the trial has enrolled
60
Results
This study did not identify hepatotoxicity and any side effects of galloylated catechin-containing supplements.
Results date posted
| 2023 | Year | 11 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(1)Age is between 20 to < 65 years old on the date of consent
(2)LDL-cholesterol level is 159 mg/dL or less, and BMI is < 30
Participant flow
From 184 individuals, we selected 60 (30 allocated to the CAT group and 30 allocated to the placebo group) who fulfilled the inclusion criteria and did not violate any of the exclusion criteria. All subjects completed the study.
Adverse events
A total of 21 adverse events were identified in both groups (CAT; 13 events; placebo; 8 events) during the study period through interviews and examination of subjective and objective symptoms. There were 2 cold-related events with CAT and 2 with placebo, 5 gastrointestinal events with CAT and 3 with placebo, and 1 dental event with CAT and 0 with placebo. The other events were 5 on CAT and 3 on placebo. There was no clear difference in the number of adverse events between the two groups. There were five events graded as 'moderate' for both CAT and placebo, and no events were graded as 'severe'. The principal investigator determined that all events were 'unrelated' or 'probably unrelated' to the study material. Therefore, there were no side effects from CAT.
Outcome measures
Influence on liver function and Hematological examination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 18 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050232
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