UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034932
Receipt number R000039833
Scientific Title Verification test of improvements in skin condition by intake of amla extract and fish collagen peptide.
Date of disclosure of the study information 2018/12/01
Last modified on 2019/02/21 15:21:30

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Basic information

Public title

Verification test of improvements in skin condition by intake of amla extract and fish collagen peptide.

Acronym

Improvements in skin condition by intake of amla extract and fish collagen peptide.

Scientific Title

Verification test of improvements in skin condition by intake of amla extract and fish collagen peptide.

Scientific Title:Acronym

Improvements in skin condition by intake of amla extract and fish collagen peptide.

Region

Japan


Condition

Condition

Healthy female

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate of the effects of amla extract and fish collagen peptide on skin condition.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Collagen density in derma (0w, 8w)

Key secondary outcomes

Moisture content of the stratum corneum (0w, 8w).
The image analysis of the skin surface (0w, 8w).
Oxidative stress markers (8-OHdG and IPs) (0w, 8w).
Urine metabolite (0w, 8w).
Glycation markers (0w, 8w).
Improvement of symptoms (0w, 4w, 8w).


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of test food containing amla extract and collagen peptide in 8 weeks.

Interventions/Control_2


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

32 years-old <=

Age-upper limit

58 years-old >=

Gender

Female

Key inclusion criteria

(1)Healthy females between the ages of 20 and 65.
(2)Individuals whose written informed consent has been obtained.

Key exclusion criteria

(1)Subjects with allergies to raw materials for test foods.
(2)Subjects who take healthy foods obtaine amla extract and fish collagen peptide.
(3)Subjects who routinely take healthy foods.
(4)Subjects who has a factor (diseases such as atopic dermatitis and hives, inflammation, eczema, trauma, breakouts, warts, blemishes, etc. or traces) influencing the test at evaluation site.
(5)Subjects with experience in cosmetic medicine (Botox injections, hyaluronic acid, collagen infusion, photofacial, etc.) at the evaluation site or who are expected to undergo the test period.
(6)Subjects who has received a special skin care treatment (beauty salon, esthetic, etc.) for the evaluation site within the past four weeks or is expected to undergo during the examination period.
(7)Subjects who changed the basic cosmetics and sunscreen material used for the evaluation site within the past four weeks, or newly started using it.
(8)Night Shift and day and night shift workers.
(9)Subjects who has received a treatment (hormone replacement therapy, drug therapy, exercise therapy, diet, etc.) at a medical institution for the treatment or prevention of disease and is deemed to be in need of treatment at the time of consent acquisition.
(10)Glucose metabolism, lipid metabolism, liver function, renal function, heart, cardiovascular, respiratory tract, endocrine system, immune system, subjects with a history of serious diseases or psychiatric disorders of the nervous system.
(11)subjects who has dependence of drug and alcohol.
(12)Subjects with allergies to cosmetics or foods.
(13)Pregnant women, those who may be pregnant, lactating women, or women who hope to become pregnant during the study period.
(14)Subjects who has participated in other human studies within the past four weeks, or subjects who plan to participate in other human studies during the planned period of the study.
(15)Subjects who were considered inappropriate for the study by an investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sumio Kondo

Organization

Medical corporation Kenshokai, Fukushima healthcare center

Division name

Internal medicine

Zip code


Address

2-12-16, Tamagawa, Fukushima-ku, Osaka

TEL

06-6882-1130

Email

s.kondo@drc-web.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taishi Koyama

Organization

Miki Corporation

Division name

Institure for Health science

Zip code


Address

12-4, Naruohama 3, Nishinomiya, Hyogo

TEL

0798-43-1870

Homepage URL


Email

koyama@mikiprune.co.jp


Sponsor or person

Institute

Miki Corporation

Institute

Department

Personal name



Funding Source

Organization

Miki Corporation

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


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



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 01 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

2018 Year 09 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 12 Month 01 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

2018 Year 11 Month 19 Day

Last modified on

2019 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name