UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044543 |
|---|---|
| Receipt number | R000050891 |
| Scientific Title | Safety Evaluation for Excessive Ingestion of Coffee-Derived Chlorogenic Acids: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2021/12/16 16:13:49 |
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Basic information
Public title
Safety Evaluation for Excessive Ingestion of Coffee-Derived Chlorogenic Acids: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Acronym
Safety Evaluation for Excessive Ingestion of Coffee-Derived Chlorogenic Acids
Scientific Title
Safety Evaluation for Excessive Ingestion of Coffee-Derived Chlorogenic Acids: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Scientific Title:Acronym
Safety Evaluation for Excessive Ingestion of Coffee-Derived Chlorogenic Acids
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the food safety containing 3 times high amount of recommended coffee-derived chlorogenic acids for 4 weeks daily ingestion in a randomized, double-blind, placebo-controlled, parallel group comparison study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The pattern, severity and frequency of side effects related to ingestion of the test food during the ingestion period (4 weeks) and the post ingestion period (2 weeks).
Key secondary outcomes
The pattern, severity and frequency of adverse events during the ingestion period (4 weeks) and the post ingestion period (2 weeks).
Body composition (BW, BFP, and BMI), vital sign (BP measured at the hospital, and heart rate), hematological test (WBC, RBC, Hb, Ht, and Plt), biochemical test (AST, ALT, gamma-GTP, ALP, LDH, FIB-4 index, BUN, CRE, UA, TC, LDL-C, HDL-C, TG, fasting blood glucose, HbA1c, total protein, albumin, total bilirubin, A/G ratio, CPK, Na, Cl, K, Ca, P, Mg, and Fe) and urine analysis (pH, protein, sugar, urobilinogen, bilirubin, ketone bodies, and occult blood) after 2 and 4 weeks of ingestion and 2weeks after the end of ingestion.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion 4.5 g of decaffeinated green coffee bean extract powder for 4 weeks.
Interventions/Control_2
Daily ingestion 4.5 g of lactose powder 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. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2. Subjects whose TG is >= 30 mg/dl and <= 149 mg/dl.
Key exclusion criteria
1. Subjects who are under physician's advice, treatment and/or medication for dyslipidemia and/or diabetes.
2. Subjects with familial hypercholesterolemia.
3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal disease, and/or affected with infectious diseases requiring reports to the authorities.
4. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
5. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data.
6. Subjects with severe anemia.
7. Pre- or post-menopausal women complaining of obvious physical changes.
8. Subjects who are at risk of having allergic reactions to drugs, foods especially based on coffee, milk, egg, wheat, shrimp, soybean, chicken, and/or pork.
9. Subjects with lactose intolerance.
10. Subjects who regularly take medicines, functional foods, and/or supplements which would affect lipid metabolism.
11. Subjects who regularly take medicines, functional foods and/or supplements which would affect glucose metabolism.
12. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
13. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study.
14. Pregnant or lactating women or women who expect to be pregnant during this study.
15. Subjects who currently participate in other clinical trials, or participate within the last 4 weeks prior to the study.
16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | NISHIHIRA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Therabiopharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.ac.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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050891
