UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025185 |
|---|---|
| Receipt number | R000028275 |
| Scientific Title | Evaluation of foods by using laboratory tests of human being who intake them |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/12/14 10:25:32 |
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Basic information
Public title
Evaluation of foods by using laboratory tests of human being who intake them
Acronym
Evaluation of foods by using laboratory tests of human being who intake them
Scientific Title
Evaluation of foods by using laboratory tests of human being who intake them
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazumasa Isobe |
Organization
Institute of Medicine, Tsukuba University
Division name
Laboratory Medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba City, Ibaraki Prefecture
TEL
029-853-3367
k-isobe@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumasa Isobe |
Organization
Institute of Medicine, Tsukuba University
Division name
Laboratory Medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba City, Ibaraki Prefecture
TEL
029-853-3367
Homepage URL
k-isobe@md.tsukuba.ac.jp
Sponsor or person
Institute
Institute of Medicine, Tsukuba University
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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 | 02 | Month | 28 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028275
