UMIN-CTR Clinical Trial

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

Healthy female

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Miki Corporation

Institute

Department

Personal name

Organization

Miki Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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