UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013933
Receipt No. R000016236
Scientific Title Effects of food containing Kurozu Moromi and garlic powder on immune function : a randomized, double blind, placebo-controlled study
Date of disclosure of the study information 2014/05/12
Last modified on 2014/11/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of food containing Kurozu Moromi and garlic powder on immune function : a randomized, double blind, placebo-controlled study
Acronym Effects of food containing Kurozu Moromi and garlic powder on immune function
Scientific Title Effects of food containing Kurozu Moromi and garlic powder on immune function : a randomized, double blind, placebo-controlled study
Scientific Title:Acronym Effects of food containing Kurozu Moromi and garlic powder on immune function
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the effects of ingestion of food containing Kurozu Moromi and garlic powder for 8 consecutive weeks on immune function in subjects with lower salivary secretory immunoglobulin A (sIgA) secretion rate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immune function (salivary sIgA secretion rate, CD4, CD8, CD4/CD8 ratio)
Key secondary outcomes cytokine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 Ingestion of food containing Kurozu Moromi and garlic powder for 8 consecutive weeks
Interventions/Control_2 Ingestion of placebo (food without Kurozu Moromi and garlic powder) for 8 consecutive weeks
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
30 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1) An age 30 years or older and up to 60 years
2) A lower salivary secretory immunoglobulin A secretion rate
Key exclusion criteria 1) Subjects who consume food containing Kurozu Moromi and garlic
2) Subjects routinely taking dietary supplements which may influence immune function
3) Subjects who has history of the allergic disease
4) Subjects who are under medication (e.g., hyposensitization) which may influence the outcome of the study
5) Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care
6) Subjects who has oral or dental problems with bleeding
7) Night and day shift worker or manual laborer
8) Subjects who has carries out an intense activity (e.g., marathon race)
9) Subjects who cannot carry out a procedure of various inspection by the rule during the study period
10) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor
11) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion
12) Subjects with allergies to the products used in the study
13) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination
14) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
17) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1) Norimasa Sato, 2) Takayuki Azuma
Organization 1) Umeda Oak Clinic
2) Yaesu Sakura dori Clinic
Division name Internal Medicine
Zip code
Address 1) 2-6-6 sonesaki, kita-ku, Osaka 2) 1-6-6 yaesu, chuo-ku, Tokyo
TEL 03-6214-1285.06-6130-8735
Email t-azuma@y-sakuradoori.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Shimada
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address 1-20-2 Ebisunishi, shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email ttcpwr2001@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization Kenkoukazoku 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
Address
Tel
Email

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
2014 Year 05 Month 12 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
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
2014 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 13 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 10 Month 01 Day

Other
Other related information Subgroup analyses are going to be performed in immune function
(Principal investigator's E-mail adress:n-sato@umeda-oak-clinic.com)

Management information
Registered date
2014 Year 05 Month 12 Day
Last modified on
2014 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016236

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.