UMIN-CTR Clinical Trial

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
Email	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
Email	mshmz@cc.tuat.ac.jp

Sponsor
Institute	Tokyo University of Agriculture and Technology
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021838