UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of foods by using laboratory tests of human being who intake them
Title of the study (Brief title)	Evaluation of foods by using laboratory tests of human being who intake them
Region	Japan

Condition
Condition	nutrients deficiency, hypercholesterolemia, arteriosclerosis
Classification by specialty	Laboratory medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We usually evaluate the efficacy of foods by the constituents. However, the absorption efficacy is dependent on individuals and vary by individual. We evaluate foods nutrients and fubctions by blood testing of humans who intake them.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	We evaluate the anti-oxidative effects of beta-carotene, the effects of zinc on enzyme activities and the effects of hydrogen molecule on the levels of cholesteroles.
Key secondary outcomes	monocyte, hsCRP

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	hydrogen enriched water, 900ml/day, for 8 weeks
Interventions/Control_2	vegetable juice, 200mlday, for 12 weeks
Interventions/Control_3	zinc supplement, 15 mg/day, for 20 days
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	LDL-C >120mg/dl beta-carotene <20 ug/dl zinc <60 ug/dl
Key exclusion criteria	under medical treatment
Target sample size	60

Research contact person
Name of lead principal investigator	Kazumasa Isobe
Organization	Institute of Medicine, Tsukuba University
Division name	Laboratory Medicine
Address	Tennodai 1-1-1, Tsukuba City, Ibaraki Prefecture
TEL	029-853-3367
Email	k-isobe@md.tsukuba.ac.jp

Public contact
Name of contact person	Kazumasa Isobe
Organization	Institute of Medicine, Tsukuba University
Division name	Laboratory Medicine
Address	Tennodai 1-1-1, Tsukuba City, Ibaraki Prefecture
TEL	029-853-3367
Homepage URL
Email	k-isobe@md.tsukuba.ac.jp

Sponsor
Institute	Institute of Medicine, Tsukuba University
Institute
Department

Funding Source
Organization	Institute of Medicine, Tsukuba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	筑波大学医学医療系

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 04 Month 30 Day
Date trial data considered complete	2019 Year 06 Month 30 Day
Date analysis concluded	2019 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Beta-carotene levels varied among individuals and correlated with their absorption ability. Zinc levels also varied among individuals but not correlated with their pre-supplementaion levels. Anti-inflammatory, anti-oxidative effects of molecular hydrogen in healthy people were not observed.
Other related information

Management information
Registered date	2016 Year 12 Month 08 Day
Last modified on	2018 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028275