UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018888 |
|---|---|
| Receipt number | R000021838 |
| Scientific Title | Foods with Function Claims: Empirical studies for "Mibyo (presymptomatic state) prevention", "Health Promotion", "Become healthy", "Can walk lightly" and "Rejuvenate" by intake of eggshell membrane dietary supplement, TO-II BEAUTY EVOLUTION |
| Date of disclosure of the study information | 2015/09/02 |
| Last modified on | 2021/03/06 23:06:09 |
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Basic information
Public title
Foods with Function Claims: Empirical studies for "Mibyo (presymptomatic state) prevention", "Health Promotion", "Become healthy", "Can walk lightly" and "Rejuvenate" by intake of eggshell membrane dietary supplement, TO-II BEAUTY EVOLUTION
Acronym
Empirical studies on the effects of eggshell membrane dietary supplement
Scientific Title
Foods with Function Claims: Empirical studies for "Mibyo (presymptomatic state) prevention", "Health Promotion", "Become healthy", "Can walk lightly" and "Rejuvenate" by intake of eggshell membrane dietary supplement, TO-II BEAUTY EVOLUTION
Scientific Title:Acronym
Empirical studies on the effects of eggshell membrane dietary supplement
Region
| Japan |
Condition
Condition
Aging
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the "Mibyo (presymptomatic state) prevention", "Health Promotion", "Become healthy", "Can walk lightly" and "Rejuvenation" effects of taking oral eggshell membrane supplements
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of lung function, skin elasticity, and diversity of intestinal microflora after two months of taking eggshell membrane supplements.
Key secondary outcomes
Maximal oxygen uptake, standing posture, height, weight, BMI, dietary survey, heart rate, respiratory rate, walking speed, resting pulse, ventilatory work threshold, grip strength, blood cytokine hormone, blood test, urine test, sit-ups, psychological test, arterial stiffness, body composition, zigzag walk, back muscle strength, leg muscle strength, dustpan, repetitive lateral jump, long sit Body bending, long sit forward bending, liver stiffness, back skin elasticity, video recording, two-step test, information on lifestyle, arm skin moisture, oil, and transpiration, skin stratum corneum lipid profile measurement, and bone density measurement (all assessed before, 3 weeks, 4 weeks, 8 weeks, and 12 weeks after intake)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of eggshell membrane contained supplements (During 3 months, 4 tablets in every morning and evening)
Interventions/Control_2
Oral intake of eggshell membrane removed supplements (During 3 months, 4 tablets in every morning and evening)
Interventions/Control_3
Oral intake of placebo tablets with all components of the supplements removed (During 3 months, 4 tablets in every morning and evening)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy males and females older than 20 years and younger than 65 years, 30 in total number
Key exclusion criteria
Persons suffering from diseases, persons who are taking-ingested drugs and foods to bring any influence on the experiment, persons who can not tolerate the experiment physically, smokers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Watanabe |
Organization
Tokyo University of Agriculture and Technology
Division name
Graduate School of Engineering, Department of Applied Chemistry
Zip code
Address
2-24-16 Nakacho, Koganei, Tokyo
TEL
042-388-7289
toshi@cc.tuat.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Shimizu |
Organization
Tokyo University of Agriculture and Technology
Division name
Grad Sch of Eng, Dept of Appl Chem
Zip code
Address
2-24-16 Nakacho, Koganei, Tokyo
TEL
042-388-7539
Homepage URL
mshmz@cc.tuat.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture and Technology
Institute
Department
Personal name
Funding Source
Organization
Almado Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
東京農工大学(東京都)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
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 | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021838
