UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017920 |
|---|---|
| Receipt number | R000020772 |
| Scientific Title | Double-Blind, Placebo-Controlled, Parallel Group Comparison Study for the Daily Ingestion of the "Taisetsu Hana no Mai No.1" (Grifola frondosa) on Antiatherosclerotic Effect |
| Date of disclosure of the study information | 2015/06/16 |
| Last modified on | 2017/06/15 13:57:13 |
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Basic information
Public title
Double-Blind, Placebo-Controlled, Parallel Group Comparison Study for the Daily Ingestion of the "Taisetsu Hana no Mai No.1" (Grifola frondosa) on Antiatherosclerotic Effect
Acronym
Antiatherosclerotic Effect by Daily Ingestion of Grifola frondosa (a polypore mushroom)
Scientific Title
Double-Blind, Placebo-Controlled, Parallel Group Comparison Study for the Daily Ingestion of the "Taisetsu Hana no Mai No.1" (Grifola frondosa) on Antiatherosclerotic Effect
Scientific Title:Acronym
Antiatherosclerotic Effect by Daily Ingestion of Grifola frondosa (a polypore mushroom)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical usefulness of antiatherosclerotic by investigating effects from daily ingestion of "Taisetsu Hano no Mai No.1" (Glifora frondosa) for 8 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Arteriosclerotic index
Key secondary outcomes
TC, LDL-C, HDL-C, TG, non HDL-C, ox-LDL, TBARS, hs-CRP, adiponectin, fasting blood glucose, HbA1c, body weight, BMI, body fat rate
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the grifola frondosa extract tablets daily for 8 weeks.
Interventions/Control_2
Ingestion of the placebo tablets daily for 8 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
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects whose arteriosclerotic index is more than 2.0.
2. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
1. Subjects who are under treatment and medication for hyperlipidemia and diabetes.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal and / or endocrine and metabolic disorders, or affected with an infectious disease which is required to report to the authorities.
3. Subjects with familial hypercholesterolemia.
4. Subjects who have a history of gastrectomy, gastrorrhaphy, enterectomy and/ or other serious gastrointestinal surgeries.
5. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
6. Subjects who have a serious anemia.
7. Pre- or post-menopausal women having obvious changes in physical condition.
8. Subjects who have a history of allergy or sensitivity to medicine and / or food (especially mushrooms).
9. Subjects who regularly take drugs, functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols, dietary fiber, etc.) which would affect the blood lipid levels.
10. Subjects who regularly take drugs, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol etc.) which would affect blood glucose.
11. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
12. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood fractions within 2 weeks prior to this study.
13. Pregnant or lactating women or women expect to be pregnant during the clinical trial.
14. Subjects who participated in other clinical trials within the last one month prior to the clinical trial.
15. Any other medical reasons judged by the doctor in charge.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
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 | |
| Middle name | |
| Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries, Government of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Forest Products Research Institute, Forest Research Department, Local Independent Administrative Agency Hokkaido Research Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 06 | Month | 16 | 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
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 29 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 17 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 24 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020772
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