UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022009 |
|---|---|
| Receipt number | R000025361 |
| Scientific Title | Effect of functional foods on bodily function |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2016/11/15 17:16:39 |
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Basic information
Public title
Effect of functional foods on bodily function
Acronym
Effect of functional foods on bodily function
Scientific Title
Effect of functional foods on bodily function
Scientific Title:Acronym
Effect of functional foods on bodily function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to investigate whether physical and psychological condition, the autonomic nervous system and immunoglobulin A in the saliva and stool could change by functional foods in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sIgA level in saliva and stool
Key secondary outcomes
Autonomic nerves activity level by heart rate variability.
Sympathetic nerves activity: low frequency(LF)/ high frequency(HF)
Sympathetic nerves activity: HF
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Placebo: dextrin(14days)
wash out(14days)
Active Hexose Correlated Compound: AHCC(14days)
Interventions/Control_2
Active Hexose Correlated Compound: AHCC(14days)
wash out(14days)
Placebo: dextrin(14days)
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
| 16 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 16-29 years.
2. Person that informed consent was provided.
Key exclusion criteria
1. Person having a disease.
2. Person who takes medicine.
3. Current smokers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Hisajima |
Organization
University of Teikyoheise Faculty of Health Care
Division name
Department of acupuncture and Moxibustion.
Zip code
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL
035-843-3111
hisajimatatsuya@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Hisajima |
Organization
University of Teikyoheise Faculty of Health Care
Division name
Department of acupuncture and Moxibustion.
Zip code
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL
035-843-3111
Homepage URL
hisajimatatsuya@mac.com
Sponsor or person
Institute
University of Teikyoheise Faculty of Health Care. Department of acupuncture and Moxibustion.
Institute
Department
Personal name
Funding Source
Organization
University of Teikyoheise
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 02 | Month | 01 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 21 | Day |
Last modified on
| 2016 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025361
