UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044733 |
|---|---|
| Receipt number | R000051090 |
| Scientific Title | Effect of Single Ingestion of Coffee Chlorogenic Acid on Postprandial Serum Triglyceride Levels: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study |
| Date of disclosure of the study information | 2021/07/05 |
| Last modified on | 2022/04/01 18:05:36 |
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Basic information
Public title
Effect of Single Ingestion of Coffee Chlorogenic Acid on Postprandial Serum Triglyceride Levels: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Acronym
Beneficial Effects of Coffee Chlorogenic Acid on Postprandial Serum Triglyceride Levels
Scientific Title
Effect of Single Ingestion of Coffee Chlorogenic Acid on Postprandial Serum Triglyceride Levels: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Scientific Title:Acronym
Beneficial Effects of Coffee Chlorogenic Acid on Postprandial Serum Triglyceride Levels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove clinical benefits associated with single ingestion of coffee chlorogenic acid on postprandial serum triglyceride levels in a randomized, double-blind, placebo-controlled, crossover study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Delta TG, incremental area under the curve (iAUC) of TG (0 to 6 hours)
Key secondary outcomes
TG, area under the curve (AUC) of TG, RLP-C, delta RLP-C, AUC of RLP-C, iAUC of RLP-C, NEFA, delta NEFA, AUC of NEFA, iAUC of NEFA, blood glucose, delta blood glucose, AUC of blood glucose, iAUC of blood glucose, insulin, delta insulin, AUC of insulin, iAUC of insulin (0 to 6 hours)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Single ingestion of decaffeinated green coffee bean extract powder with high-fat meal, and take washout period for 1 week, and then, single ingestion of placebo powder with high-fat meal.
Interventions/Control_2
Single ingestion of placebo powder with high-fat meal, and take washout period for 1 week, and then, single ingestion of decaffeinated green coffee bean extract powder with high-fat meal.
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 fasting serum triglyceride levels are 100 mg/dl or more and 149 mg/dl or less.
3. Subjects with relatively high postprandial serum triglyceride levels.
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 diseases, and/or affected with infectious diseases requiring reports to the authorities.
4. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
5. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
6. Subjects with severe anemia.
7. Pre- or post-menopausal women complaining of obvious physical changes.
8. Subjects who experienced unpleasant feeling during drawing blood in the past.
9. Subjects who are at risk of having allergic reactions to drugs or foods especially based on coffee, milk, egg, wheat, shrimp, soybean, chicken and/or pork.
10. Subjects with lactose intolerance.
11. Subjects who regularly take medicine, functional foods, and/or supplements which would affect lipid metabolism.
12. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism.
13. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
14. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the screening tests.
15. Pregnant or lactating women or women who expect to be pregnant during this study.
16. Subjects who currently participate in other clinical trials, or participate within the last 4 weeks prior to the study.
17. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size
24
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, 069-8585, 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, 069-8585, 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 | 07 | Month | 05 | 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 | 07 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 09 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 16 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051090
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| Registered date | File name |
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