UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048945 |
|---|---|
| Receipt number | R000055765 |
| Scientific Title | The influence of Chlorella supplementation on blood vitamin D and vitamin K concentration in healthy adults: a randomized, controlled, open-label, parallel-group study. |
| Date of disclosure of the study information | 2022/09/15 |
| Last modified on | 2022/09/15 15:57:23 |
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Basic information
Public title
The influence of Chlorella supplementation on blood vitamin D and vitamin K concentration in healthy adults.
Acronym
The influence of Chlorella supplementation on blood vitamin D and vitamin K concentration in healthy adults.
Scientific Title
The influence of Chlorella supplementation on blood vitamin D and vitamin K concentration in healthy adults: a randomized, controlled, open-label, parallel-group study.
Scientific Title:Acronym
The influence of Chlorella supplementation on blood vitamin D and vitamin K concentration in healthy adults.
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the influence of Chlorella supplementation on blood vitamin D and vitamin K concentration in healthy adults.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The blood concentrations of vitamin D and vitamin K at 2 and 4 weeks after Chlorella supplementation.
Key secondary outcomes
1. The blood concentrations of vitamin B1, vitamin B2, vitamin B6, vitamin B12, folic acid, and total homocysteine at 2 and 4 weeks after Chlorella supplementation.
2. Daily amount of dietary nutrient intake during the study period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Stop to taking Chlorella or multiple supplements containing, vitamin D, vitamin K, and vitamin B a month before the start of the trial.
-After the start of the trial-
Duration: Four weeks
Test food: Chlorella tablets
Administration: Take 8g with water per day.
If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Stop to taking Chlorella or multiple supplements containing, vitamin D, vitamin K, and vitamin B a month before the start of the trial.
-After the start of the trial-
Duration: Four weeks
Test food: None
Administration: None
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
1.Subjects who are pregnant, lactation.
2.Subjects who are taking warfarin.
3.Subjects who are taking other alternative medicine or supplements.
4. Subjects with serious medical illness, such as hepatic disorder, nephropathy and cardiopathy.
5. Subjects who are judged as ineligible to participate in this study by the physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Noguchi |
Organization
Chlorella Industry Co., Ltd
Division name
Department of Research & Development
Zip code
833-0056
Address
1343 Hisatomi, Chikugo, Fukuoka, Japan
TEL
0942-52-2191
naoto_noguchi@chlorella.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Imai |
Organization
Chlorella Industry Co., Ltd
Division name
Department of Research & Development
Zip code
833-0056
Address
1343 Hisatomi, Chikugo, Fukuoka, Japan
TEL
0942-52-2191
Homepage URL
yumi_imai@chlorella.co.jp
Sponsor or person
Institute
Chlorella Industry Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Chlorella Industry Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethics committee of Chlorella Industry
Address
1343 Hisatomi, Chikugo, Fukuoka, Japan
Tel
0942-52-2191
naoto_noguchi@chlorella.co.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
32
Results
Blood levels of 25-hydroxyvitamin D and vitamin K1 significantly increased after Chlorella supplementation.
Results date posted
| 2022 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy subjects aged 19-48 years
Participant flow
Randomized (n=32)
Allocation: Control (n=16), Chlorella (n=16)
Lost to follow-up: Control (n=1), Chlorella (n=1)
Analysis: Control (n=15), Chlorella (n=15)
Adverse events
None
Outcome measures
Blood vitamin concentrations.
Mean intake levels of vitamin.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055765
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