UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of combined effects for middle aged female about ingesting food containing amino acids and exercise on facial muscles and features.
Acronym	Evaluation of combined effects for middle aged female about ingesting food containing amino acids and exercise on facial muscles and features.
Scientific Title	Evaluation of combined effects about ingesting food containing amino acids and exercise on facial muscles and features : a randomized, placebo-controlled, double-blind study
Scientific Title:Acronym	Evaluation of combined effects about ingesting food containing amino acids and face exercise on facial muscles and features by RCT study
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines effects on facial muscles and facial shape and features in healthy middle aged female adults by ingest food containing amino acids and exercise on facial muscles.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in thickness of the central part and originating part of the zygomaticis major muscle.
Key secondary outcomes	Depth and angle of the laugh lines Angle of the laugh lines from the nose 3D facial photography Skin elasticity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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 Other
Interventions/Control_1	After daily exercise by facial equipment device, intake food (active) once a day for12 weeks.
Interventions/Control_2	After daily exercise by facial equipment device, intake of food (placebo) once a day for 12 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	40 years-old <=
Age-upper limit	55 years-old >=
Gender	Female
Key inclusion criteria	1) Japanese healthy female aged 40-54 years 2) Females who are concerned about sagging face and smile lines 3) Females with a BMI of 20-23.9
Key exclusion criteria	(1) Subjects who have a smoking habit. (2) Subjects with a history of serious diseases such as heart, liver, kidneys. (3) Subjects who have 5 or more metal objects (bolts, silver teeth, etc.) on the upper jaw. (4) Subjects with a history of other serious diseases. (5) Subjects who is taking medication or under medical treatment. (6) Subjects who have undergone immunosuppression or other treatment within 3 months. (7) Subjects who may develop allergies related to the study. (8) Subjects with chronic skin diseases such as atopic dermatitis. (9) Subjects who have scars, warts, pimples, permanent makeup, burns, etc. on the face that affect the research target area. (10) Claustrophobic subjects. (11) Subjects receiving "hormone replacement therapy". (12) Subjects who have experience in aesthetic medicine that affect the research target area. (13) Subjects using supplements. (14) Subjects with irregular lifestyle habits such as eating, sleeping and skin care. (15) Subjects drinking heavily. (16) Subjects who can't keep the daily records. (17) Subjects who is planning to get pregnant during the test period after the day of informed consent or is currently pregnant and lactating. (18) Subjects who participate in other clinical trial. (19) Subjects whose family members work for companies related to the sale of beauty equipment and supplements. (20) Subjects judged by the physician to be unsuitable for this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuuji Middle name Last name Suda
Organization	Ajinomoto Co., Inc.
Division name	Institute of Food Sciences and Technologies
Zip code	210-8681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL	080-1002-7371
Email	yuuji.suda.53c@asv.ajinomoto.com

Public contact
Name of contact person	1st name Ikuko Middle name Last name Sasahara
Organization	Ajinomoto Co., Inc.
Division name	Institute of Food Sciences and Technologies
Zip code	210-8681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL	070-4017-9656
Homepage URL
Email	ikuko.sasahara.ve8@asv.ajinomoto.com

Sponsor
Institute	KSO Co., Ltd.
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Aging Imaging laboratory, Inc. YA-MAN Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Ajinomoto Co., Ltd
Address	1-15-1, Kyobashi, Chuo-ku, Tokyo
Tel	+81-3-5250-8134
Email	ajinomoto_irb@ajinomoto.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	株式会社ケイ・エス・オー（東京都）/KSO Co., Ltd. (Toky)

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 31 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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 07 Day
Date of IRB	2022 Year 09 Month 07 Day
Anticipated trial start date	2022 Year 10 Month 31 Day
Last follow-up date	2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 10 Month 31 Day
Last modified on	2022 Year 10 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056123