UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050034 |
|---|---|
| Receipt number | R000056998 |
| Scientific Title | A study to evaluate on improvement of skin conditions by the supplementation with lactic acid bacteria - placebo-controlled, randomized, double blind, parallel-group comparison method - |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/07/16 11:13:10 |
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Basic information
Public title
A study on improvement of skin conditions by the supplementation with lactic acid bacteria
Acronym
A study on improvement of skin conditions by lactic acid bacteria
Scientific Title
A study to evaluate on improvement of skin conditions by the supplementation with lactic acid bacteria - placebo-controlled, randomized, double blind, parallel-group comparison method -
Scientific Title:Acronym
A placebo-controlled, randomized, double-blind, parallel-group study to evaluate of lactic acid bacteria on the skin functions
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects on the skin of healthy women in Japan between the ages of over 30 and under 50 who continuously ingested the test food for 8 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin moisture (stratum corneum water content), Trans epidermal water loss, Skin elasticity
Key secondary outcomes
Other skin conditions (melanin content, erythema, texture, wrinkles, spots, etc.), Stratum corneum analyses, Questionnaire for skin and mental conditions, Izumo scale score, Physical parameters, Hematology parameters, Blood chemical/biochemical parameters, Urine biochemical parameters
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 1 capsule of the test food orally after breakfast for 8 weeks
Interventions/Control_2
Take 1 capsule of the placebo orally after breakfast for 8 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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1) Japanese female aged over 30 years and under 50 years at the time of the informed consent
2) Subjects who feel their skin is dry
3) Subjects who have received a sufficient explanation of the purpose and content of the study, fully have understand them, and have expressed their intention to participate in the study voluntarily in writing with their abilities to consent to participate in the study
Key exclusion criteria
Subjects who met the following exclusion criteria are excluded from the study:
1) regularly use of medicines or supplements for the skin, or regularly user of probiotics supplements
2) have skin disease symptoms such as atopic dermatitis, or scars/ inflammation at the test sites
3) have severe hay fever / allergic symptoms on face
4) have food allergies
5) have disease such as hepatic, renal, gastrointestinal, cardiac, respiratory, endocrine, or metabolic diseases
6) have a history of cosmetic or medical treatments, hormone replacement therapy within the past 6 months, or intend to undergo such treatments during the study period
7) cannot refrain from undergoing tanning / visiting strong sunlight area during the study period
8) cannot refrain from direct sunlight for sports, etc
9) have digestive diseases / a history of digestive surgery
10) Pregnant, lactating, or intending to become pregnant
11) Drinker (20 g/day or more of pure alcohol for 4 or more days per week), or cannot abstain from alcohol for 2 days prior to each examination.
12) Shift workers, late night workers, or have a plan of travel abroad
13) cannot avoid changing / addition of skin care products
14) cannot avoid shaving the skin for 7 days prior to the date of each examination
15) participated in other studies within 1 month prior to the date of informed consent, or have a plan to participate in other studies during this study.
16) deemed inappropriate by the corresponding investigator with a medical license
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Iwao |
| Middle name | |
| Last name | Funahashi |
Organization
Kaneka Corporation
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
050-3133-6397
Iwao.Funahashi@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Jinko |
| Middle name | |
| Last name | Sawashita |
Organization
Kaneka Corporation
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
530-8288
Address
2-3-18 Nakanoshima, Kita-ku, Osaka, Japan
TEL
050-3133-6396
Homepage URL
Jinko.Sawashita@kaneka.co.jp
Sponsor or person
Institute
Kaneka Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Center
Address
2972-8-603 Ishikawa-cho, Hachioji, Tokyo, Japan
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.jp
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
| 2024 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Not set
Publication of results
Unpublished
Result
URL related to results and publications
Not set
Number of participants that the trial has enrolled
60
Results
Healthy adult women who were concerned about dry skin consumed food containing heat-sterilized lactic acid bacteria for eight weeks, afyer then, they were improved in some objective indicators of skin condition and in the effect of mind (VAS assessment).
In addition, there were no safety issues with consuming this food.
Results date posted
| 2024 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In brief;
(1) Healthy women between 30 and 50 years of age at the time of consent
(2) Those who are concerned about dry skin
(3) Those who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Participant flow
Recruitment, Screening (visit to hospital, to -2 weeks), Pre-observation (-1 week to the day before intake begins), and 8-week intake (visit to hospital for examination: 0, 5, and 8 weeks)
Adverse events
There were no problematic adverse events in hematology, blood biochemistry, urine biochemistry, and other safety endpoints.
In addition, there were no adverse events on the skin condition based on dermatologist examination.
Outcome measures
(1) skin: stratum corneum moisture content, transepidermal water loss, elasticity, melanin content, erythema, texture, wrinkles, spots, pore and others
(2) Questionnaire (VAS): about skin, about mind
(3) Gastrointestinal score: Izumo scale score
(4) Safety: physical examination (blood pressure, pulse rate, body weight), hematology and blood biochemistry tests, urine biochemistry tests, subjective and objective symptoms, examination by a dermatologist, and others
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056998
