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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030418
Receipt No. R000034736
Scientific Title Effect of Daily Intake of Harudori-Kombu (which picked within young in spring) on lipid metabolism: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group
Date of disclosure of the study information 2017/12/15
Last modified on 2019/05/29

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Basic information
Public title Effect of Daily Intake of Harudori-Kombu (which picked within young in spring) on lipid metabolism: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group
Acronym Beneficial Effects of Harudori-Kombu on lipid metabolism
Scientific Title Effect of Daily Intake of Harudori-Kombu (which picked within young in spring) on lipid metabolism: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group
Scientific Title:Acronym Beneficial Effects of Harudori-Kombu on lipid metabolism
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To prove clinical benefits associated with 6 week daily intake of Harudori-Kombu on lipid metabolism. Additionally to examine reduction of body fat rate, improvement of glucose metabolism and blood pressure to evaluate the comprehensive effects of Harudori-Kombu for health promotion and health maintenance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes TC, LDL-C, HDL-C, TG, LDL-C/HDL-C and non-HDL at 2 and 6 weeks after beginning the intake of test food.
Key secondary outcomes fasting blood glucose, Insulin, HbA1c, HOMA-IR, adiponectin, body weight, body fat rate, BMI, waist circumference, blood pressure

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 Daily intake of 9 capsules of active test food for 6 weeks.
Interventions/Control_2 Daily intake of 9 capsules of placebo food for 6 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
30 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects whose LDL-C is >= 120 mg/dl and <160 mg/dl.
2. Subjects whose BMI is >= 22 kg/m2 and <30 kg/m2.
3. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria 1. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia, diabetes, and/or thyroid disease.
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 are at risk of having allergic reactions to drugs or foods especially based on seaweed and/or gelatin.
9. Subjects who regularly take medicine, functional foods, and/or supplements which would affect lipid metabolism.
10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism.
11. Heavy smokers, alcohol addicts or subjects with eating disordered lifestyle.
12. 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 current study.
13. Pregnant or lactating women or women who expect to be pregnant during this study.
14. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
15. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 70

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
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Health Information Science Research Center
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Northern Advancement Center for Science & Technology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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
2017 Year 12 Month 15 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
2017 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 12 Day
Last follow-up date
2018 Year 03 Month 03 Day
Date of closure to data entry
2018 Year 04 Month 10 Day
Date trial data considered complete
2018 Year 04 Month 25 Day
Date analysis concluded
2018 Year 08 Month 10 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 15 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034736

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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