UMIN-CTR Clinical Trial

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
Last 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
1st 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