UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041443 |
|---|---|
| Receipt number | R000047309 |
| Scientific Title | Exploratory test on the influence of continuous intake of fulvic acid on the body |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2021/02/15 12:26:05 |
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Basic information
Public title
Exploratory test on the influence of continuous intake of fulvic acid on the body
Acronym
Exploratory test on the influence of continuous intake of fulvic acid on the body
Scientific Title
Exploratory test on the influence of continuous intake of fulvic acid on the body
Scientific Title:Acronym
Exploratory test on the influence of continuous intake of fulvic acid on the body
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Do an exploratory evaluation of the influence on the body for women(35 to 64 years old) by fulvic acid continuous intake for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-urinary 8-OHdG
At the beginning of the test or after the intake for 12 weeks.
Key secondary outcomes
-Blood test (IL-6, hsCRP)
-Intestinal Flora(NGS)
-Physical examination (body height, body weight, BMI, lean body mass)
-Optical measurements of heavy metals , minerals test
-AGE
At the beginning of the test or after the intake for 12 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of 4 capsules of test food A* daily for 12 weeks.
*test food A and B are capsules containing either placebo 1000mg (4 capsules) or "capsule in fluvic acid" 1000mg (4 capsules).
Interventions/Control_2
Intake of 4 capsules of test food B* daily for 12 weeks.
*test food A and B are capsules containing either placebo 1000mg (4 capsules) or "capsule in fluvic acid" 1000mg (4 capsules).
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Female who are 35 years old or more and under 65 years old
Key exclusion criteria
1. Persons who have any disease and are judged to have necessary treatment by the principal investigator.
2. Persons who are taken or applied medications for the treatment in the last one month. (excluding medicine used for needed basis such as headache, menstrual cramps and colds, etc.)
3. Persons with medical history with visceral disease and blood disease.
4. Persons who are judged to have diseases by the principal investigator and result of blood test or self-report.
5. Persons with self-report of medical history within last 6 months.
6. Persons who have severe anemia.
7. Persons who have an addiction to alcohol or a mental disease.
8. Persons who are a smoker or has been smoking for within last 10 years.
9. Persons who may cause allergic symptoms to test foods.
10. Persons who received hormone replacement therapy in the past 6 months.
11. Persons who were hospitalized and received treatment in the past 6 months.
12. Persons whose life style will change during the study period.
13. Persons who plan to intake new health functional foods and supplement foods during the study period.
14. Persons who participates in other clinical studies or participated in the last 3 months or plan to participate in other clinical studies.
15. Persons who are pregnant, planning or hoping to be pregnant during the study period, currently lactating.
16. Persons who were judged as inappropriate for subjects by the principal investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Ito |
Organization
Akasaka Family Clinic
Division name
Clinic Director
Zip code
107-0052
Address
Akasaka Plaza bldg. 3F, 2-15-15 Akasaka, Minato-ku, Tokyo, JAPAN
TEL
03-5562-8825
info@afc.tokyo
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Watanabe |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
watanabe@hc-sys.jp
Sponsor or person
Institute
Akasaka Family Clinic
Institute
Department
Personal name
Funding Source
Organization
Japan Organic Mineral Inc.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2020 | Year | 08 | Month | 17 | 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
34
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
| 2020 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 17 | Day |
Last modified on
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047309
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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