UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on the immune function
Acronym	Effects of consumption of the test food on the immune function
Scientific Title	Effects of consumption of the test food on the immune function: A randomized, double-blind, placebo-controlled comparison trial
Scientific Title:Acronym	Effects of consumption of the test food on the immune function
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 effects of 4-week consumption of the test food on the immune function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The measured values of scoring of immunological vigor at four weeks after consumption (4w)
Key secondary outcomes	1. The amount of change of scoring of immunological vigor between screening (before consumption; Scr) and 4w 2. The measured values of immunological grade at 4w 3. The amount of change of immunological grade between Scr and 4w 4. The measured values of immunological vigor test*1 and intestinal flora*2 at 4w 5. The measured values of original questionnaires (the Likert scale method) at 4w 6. The amount of change of original questionnaires between Scr and 4w 7. The amount of change of immunological vigor test*1 and intestinal flora*2 between Scr and 4w 8. The ratio of subjects who were scored in each of the following items of immunological vigor at 4w: immunological grade, the score of T cells, the score of CD8+CD28+T cells, the score of ratio of CD4+/CD8+T cells, the score of naive T cells, the score of ratio of naive / memory T cells, the score of B cells, and the score of NK cells *1 immunological vigor test T lymphocyte age (upper limit), the score of T cells, the score of CD8+CD28+T cells, the score of ratio of CD4+/CD8+T cells, the score of naive T cells, the score of ratio of naive / memory T cells, the score of B cells, the score of NK cells, the number of T cells, the number of CD4+ cells, the number of CD8+ cells, the ratio of CD4+/CD8+T cells, the number of naive T cells, the ratio of naive / memory T cells, the number of B cells, the number of NK cells, the number of CD8+CD28+T cells *2 intestinal flora Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium clusterXI, Clostridium subcluster XIVa, Clostridium cluster XVIII

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: Four weeks Test food: The test foods 1, 2, and 3 Administration: Morning: Take about 3 g of the test food 1, 6 g of the test food 2, and 30 mL of the test food 3 mixed with water (about 180 mL) Daytime: Take about 3 g of the test food 1 mixed with water (about 180 mL) then take the same again more than two hours later Night: Take about 3 g of the test food 1, 6 g of the test food 2, and 30 mL of the test food 3 mixed with water (about 180 mL) * It does not matter if you take it before or after meals, right after waking up or right before bedtime. * Daily dose should be taken in several parts within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: Four weeks Test food: The placebo foods 1, 2, and 3 Administration: Morning: Take about 3 g of the placebo food 1, 6 g of the placebo food 2, and 30 mL of the placebo food 3 mixed with water (about 180 mL) Daytime: Take about 3 g of the placebo food 1 mixed with water (about 180 mL) then take the same again more than two hours later Night: Take about 3 g of the placebo food 1, 6 g of the placebo food 2, and 30 mL of the placebo food 3 mixed with water (about 180 mL) * It does not matter if you take it before or after meals, right after waking up or right before bedtime. * Daily dose should be taken in several parts within the day. If you forget to take the test food, take it as soon as you remember within the day.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who feels tired easily 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have low scoring of immunological vigor at Scr
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Function Claims," 5. Subjects who are currently taking medications (including herbal medicines) and supplements. 6. Subjects who are allergic to medicines and/or vegetables and fruits in general. 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are diagnosed with pollen allergy 10. Subjects who have an autoimmune disease 11. Subjects who are taking immunosuppressants such as steroids 12. Subjects who have received vaccination for infectious diseases such as influenza within three month 13. Subjects who are diagnosed with hemoglobinemia (iron overload) 14. Subjects who are diagnosed with Wilson's disease 15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Takara
Organization	Medical Corporation Seishinkai, Takara Clinic
Division name	Director
Zip code	141-0022
Address	9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL	03-5793-3623
Email	t-takara@takara-clinic.com

Public contact
Name of contact person	1st name Naoko Middle name Last name Suzuki
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	BOTANIC LABORATORY Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	IRB@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 02 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	22
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	2021 Year 05 Month 26 Day
Date of IRB	2021 Year 05 Month 26 Day
Anticipated trial start date	2021 Year 06 Month 03 Day
Last follow-up date	2021 Year 09 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 02 Day
Last modified on	2022 Year 02 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050718