UMIN-CTR Clinical Trial

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
Email	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
Email	watanabe@hc-sys.jp

Sponsor
Institute	Akasaka Family Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047309