UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049380 |
|---|---|
| Receipt number | R000056123 |
| 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 |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2022/10/31 21:06:17 |
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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
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
ikuko.sasahara.ve8@asv.ajinomoto.com
Sponsor or person
Institute
KSO Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056123
