UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045342
Receipt number R000051779
Scientific Title Effects of consumption of the test food on the swelling in health Japanese sucjects: An open-label trial
Date of disclosure of the study information 2021/09/01
Last modified on 2021/09/24 18:29:39

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of consumption of the test food on the swelling in health Japanese sucjects

Acronym

Effects of consumption of the test food on the swelling in health Japanese sucjects

Scientific Title

Effects of consumption of the test food on the swelling in health Japanese sucjects: An open-label trial

Scientific Title:Acronym

Effects of consumption of the test food on the swelling in health Japanese sucjects

Region

Japan


Condition

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the reduction effect of swelling with consumption of the test food.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. The measured value of the swelling volume of the lower leg*1 at two weeks after consumption (2w)

*1It is calculated by subtracting the lower leg volume in the morning from that in the evening

Key secondary outcomes

1. The measured value at 2w of the following items: the lower leg volume in the morning or evening, the facial swelling volume*2, subjective symptoms of swollen legs or face (visual analogue scale), and calf circumference (maximum circumference of the lower leg)

*2It is calculated by subtracting the face volume in the morning from that in the evening


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Two weeks
Test food: Powdered beverage containing polyphenols
Administration: Dissolve one packet with water and drink after lunch

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
* Subjects should take test food after lunch even in each test.

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


Not applicable

Gender

Female

Key inclusion criteria

1. Japanese

2. Women

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who concerns about swollen legs

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose swelling volume of the lower leg are large at Scr

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hypotension, hemorrhagic disease, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, breast-feeding, and planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

9. Subjects who have surgery within the last 14 days before the agreement to participate in this trial or plan of surgery during the consumption

10. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

4


Research contact person

Name of lead principal investigator

1st name Tsuyoshi
Middle name
Last name Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com


Public contact

Name of contact person

1st name Naoko
Middle name
Last name Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

Meiji Food Materia Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com


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

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2021 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

4

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

No longer recruiting

Date of protocol fixation

2021 Year 08 Month 25 Day

Date of IRB

2021 Year 08 Month 25 Day

Anticipated trial start date

2021 Year 09 Month 02 Day

Last follow-up date

2021 Year 10 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 09 Month 01 Day

Last modified on

2021 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051779


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name