UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041242
Receipt number R000047098
Scientific Title Safety confirmation test of long-term intake of Okra seed extract -open-label trial-
Date of disclosure of the study information 2020/09/01
Last modified on 2020/12/14 09:14:08

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Basic information

Public title

Safety confirmation test of long-term intake of Okra seed extract

Acronym

Safety confirmation test of long-term intake of Okra seed extract

Scientific Title

Safety confirmation test of long-term intake of Okra seed extract -open-label trial-

Scientific Title:Acronym

Safety confirmation test of long-term intake of Okra seed extract -open-label trial-

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the safety when intake the test foods for 12 weeks in healthy Japanese subjects

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body measurement, physical examination
Hematology test
Blood biochemistry test
Urinalysis
Doctor's questions
Assess these at screening (before intake), at 4, 8, and 12 weeks after intake

Key secondary outcomes



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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test foods for 12 consecutive weeks (3 capsules/ day)

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

20 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Healthy adult males and females between 20 to 64 years
(2) BMI: less than 30 kg/m2
(3) Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing

Key exclusion criteria

(1) Subjects who were diagnosed with liver disease, kidney disease, gastrointestinal disease, heart disease, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery
(2) Subjects who indicate abnormal parameter in liver or kidney function
(3) Subjects with a disease currently under treatment
(4) Subjects with anemia
(5) Subjects who detect abnormal values by blood test
(6) Subjects who determine ineligible by principal investigator
(7) Subjects with drug or food allergies
(8) Subjects who play high intensity sports and/or are on a diet
(9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods
(10) Subjects who are under treatment with medications (including OTC or prescribed medication)
(11) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement
(12) Subjects with smoking habit
(13) Subjects with irregular life patterns and lifestyle of reversal of day and night
(14) Subjects who have a habit of excessive eating and drinking
(15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(16) Subjects who is participating in the other study or planning to participate during the study period
(17) Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Naoki
Middle name
Last name Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal Medicine

Zip code

530-0044

Address

9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan

TEL

06-6135-5200

Email

tterashima@miula.co.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Terashima

Organization

Oneness support Co., Ltd.

Division name

Clinical trial Division

Zip code

530-0044

Address

4F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan

TEL

06-4801-8917

Homepage URL


Email

mterashima@oneness-sup.co.jp


Sponsor or person

Institute

Oneness support Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

BHN 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

Miura Clinic, Medical Corporation Kanonkai IRB

Address

9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan

Tel

06-6135-5200

Email

mterashima@oneness-sup.co.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

2020 Year 09 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

2020 Year 07 Month 28 Day

Date of IRB

2020 Year 07 Month 30 Day

Anticipated trial start date

2020 Year 08 Month 24 Day

Last follow-up date

2020 Year 11 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 07 Month 29 Day

Last modified on

2020 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name