UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041444
Receipt number R000047310
Scientific Title Effect of sea buckthorn juice on skin condition in healthy adult women: a randomized, double-blind, placebo-controlled study
Date of disclosure of the study information 2020/12/20
Last modified on 2020/08/17 17:23:19

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Basic information

Public title

Effect of sea buckthorn juice on skin condition in healthy adult women

Acronym

The study of effect of sea buckthorn juice

Scientific Title

Effect of sea buckthorn juice on skin condition in healthy adult women: a randomized, double-blind, placebo-controlled study

Scientific Title:Acronym

The study of effect of sea buckthorn juice

Region

Japan


Condition

Condition

Healthy adult women

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of sea buckthorn juice on skin condition in healthy adult women

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin quality measurement
Skin condition Visual analogue scale

Key secondary outcomes

Complete blood count
Anemia questionnaire
Urinalysis
urinary excretion question


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

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

To intake sea buckthorn juice 60ml/day for 4 weeks

Interventions/Control_2

To intake placebo juice 60ml/day for 4 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

(1) persons who is generally judged as healthy
(2) Persons who can give voluntary written consent to participate in the present trial
(3) Persons whose Hemoglobin (HGB) is less than 12.0 g/dL having a slight anemia

Key exclusion criteria

(1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2) persons who have changed their habitats to take supplements within past 4 weeks.
(3) Persons who work in night shift or in day and night shift
(4) persons who have been treated their illness or prevention in a clinic at their informed consent
(5) persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6) persons with the medical histories of alcoholism or drug dependence
(7) Persons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10) persons who will not be judged suitable to the participants by the investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Koichirou
Middle name
Last name Ohnuki

Organization

Faculty of Humanity-Oriented Science and Engineering, Kindai University

Division name

Food function science laboratory

Zip code

820-0011

Address

11-6 Kayanomori, Iiduka, Fukuoka, Japan

TEL

0948-22-5655

Email

ohnuki@fuk.kindai.ac.jp


Public contact

Name of contact person

1st name Keiko
Middle name
Last name Ohnuki

Organization

User Life Science Co., Ltd.

Division name

The research and development part

Zip code

820-0115

Address

372-3, Niho, Izuka, Fukuoka, JAPA

TEL

0948-82-3123

Homepage URL


Email

userlifesciense@gmail.com


Sponsor or person

Institute

User Life Science Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Finess Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Laboratory of Systematic Forest and Forest Products Science
Faculty of Agriculture, Kyushu University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kindai University Faculty of Humanity-Oriented Science and Engineering Committee on Ethics

Address

11-6 Kayanomori, Iiduka, Fukuoka, Japan

Tel

0948-22-5655

Email

ohnuki@fuk.kindai.ac.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

九州大学農学研究院 環境農学部門 森林圏環境資源科学研究室


Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 20 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

34

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

2019 Year 11 Month 15 Day

Date of IRB

2019 Year 03 Month 04 Day

Anticipated trial start date

2019 Year 11 Month 18 Day

Last follow-up date

2019 Year 12 Month 20 Day

Date of closure to data entry

2019 Year 12 Month 27 Day

Date trial data considered complete

2020 Year 01 Month 20 Day

Date analysis concluded

2020 Year 02 Month 20 Day


Other

Other related information



Management information

Registered date

2020 Year 08 Month 17 Day

Last modified on

2020 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047310


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name