UMIN-CTR Clinical Trial

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
Email	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
Email	hisc-acad.res@s.do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050891