UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029644 |
|---|---|
| Receipt number | R000033866 |
| Scientific Title | Effect of Powdered food on a Condition of Skin in Healthy Adult Females. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/10/28 17:17:43 |
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Basic information
Public title
Effect of Powdered food on a Condition of Skin in Healthy Adult Females.
Acronym
Effect of Powdered food on a Condition of Skin.
Scientific Title
Effect of Powdered food on a Condition of Skin in Healthy Adult Females.
Scientific Title:Acronym
Effect of Powdered food on a Condition of Skin.
Region
| Japan |
Condition
Condition
To explore the effect of powdered food supplementation on skin.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of powdered food supplementation on skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of skin condition. (measurement time: 0, 4, 8 weeks after intervention)
Key secondary outcomes
Measurement of visual analog scale. (measurement time: 0, 4, 8 weeks after intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 8weeks.
Test materials: Powdered food.
Does: 2 portions per day.
Interventions/Control_2
Duration: 8weeks.
Test materials: Powdered placebo food.
Does: 2 portions per day.
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
| 55 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy postmenopausal subjects from 55 to 65 years old.
2.BMI is >= 18.5 kg/m^2 and < 25.0 kg/m^2.
3.Subjects who concern with rough skin.
4.Subjects who keep regular daily life and sleep as possible.
5.Subjects who can visit the examination place on a fixed schedule.
6.Subjects who can cooperate with weight measurement, a questionnaire and skin measurement at the examination place.
7.Subjects who can intake test food dissolved with hot water etc., twice a day during the examination.
8.Subjects who can fill up the examination record everyday.
Key exclusion criteria
1.Subjects who have food allergy. Especially subjects who are sensitive to gelatin.
2.Subjects who have possibility of hay fever.
3.Subjects who have been medical history of physical disorder when they took supplements.
4.Subjects who are diabetes or hypercholesterolemia.
5.Subjects who take medicine and/or food for specified health use.
6.Subjects who took supplements and/or drink for improvement of skin condition within 1 month.
7.Subjects who smoke.
8.Subjects who had laser treatment and/or peeling treatment within 1 year.
9.Subjects who regularly have beauty treatment or plan to have beauty treatment.
10.Subjects who have possibility of excessive sunburn.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Inagaki, Hiroyuki |
Organization
MORINAGA & CO.,Ltd.
Division name
Research Institute
Zip code
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-2504
h-inagaki-jj@morinaga.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Inagaki, Hiroyuki |
Organization
MORINAGA & CO.,Ltd.
Division name
Research Institute
Zip code
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-2504
Homepage URL
h-inagaki-jj@morinaga.co.jp
Sponsor or person
Institute
MORINAGA & CO.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
MORINAGA & CO.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.pieronline.jp/content/article/0386-3603/47050/777
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/47050/777
Number of participants that the trial has enrolled
22
Results
These results suggested that continuous ingestion of 10 g of gelatin for 8 weeks improved skin viscoelasticity(R7)and skin condition in post-menopausal healthy volunteers with skin elasticity(R7)higher than or equal to 0.3. No side effects were noted throughout the study.
Results date posted
| 2019 | Year | 10 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
44 post-menopausal(55-65 years old)healthy volunteers.
Participant flow
44 post-menopausal(55-65 years old)healthy volunteers.
Adverse events
No side effects were noted throughout the study.
Outcome measures
Measurement of facial skin viscoelasticity and subjective evaluation of skin condition(Visual Analogue Scale/VAS)were carried out before the first ingestion(0W)and after 8 weeks(8W)of ingestion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Hiroyuki Inagaki et al.
Effects of Continuous Ingestion of Gelatin on Facial Skin Viscoelasticity and Subjective Evaluation of Skin Condition in Postmenopausal Healthy Women.
-A Randomized, Double-blind, Placebo-controlled Parallel-group, Comparison Study-
Jpn Pharmacol Ther 2019 47(5)777-87
Management information
Registered date
| 2017 | Year | 10 | Month | 20 | Day |
Last modified on
| 2019 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033866
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| Registered date | File name |
| Research case data | |
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