UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038688
Receipt number R000044097
Scientific Title A verification study of anti-obesity effects of the consumption of proteoglycan: An open-label trial
Date of disclosure of the study information 2019/11/25
Last modified on 2022/08/26 09:03:43

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Basic information

Public title

A verification study of anti-obesity effects of the test food

Acronym

A verification study of anti-obesity effects of the test food

Scientific Title

A verification study of anti-obesity effects of the consumption of proteoglycan: An open-label trial

Scientific Title:Acronym

A verification study of anti-obesity effects of the consumption of proteoglycan

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 effect of anti-obesity effects of the consumption of the test food for four weeks in healthy Japanese adult subjects whose body mass index (BMI) is relatively high.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Body fat percentage

* Assess the measured value at screening (before consumption) and at four weeks after the start of test-food consumption and calculate the amount of change.

Key secondary outcomes

1. Body weight
2. Body Mass Index
3. Muscle mass
4. Lean body mass
5. Abdominal circumference
6. Japanese Knee Osteoarthritis Measure (JKOM)
6-1. The score of visual analogue scale; VAS
6-2. The total score
6-3. The score of pain and stiffness in knees
6-4. The score of condition in daily life
6-5. The score of general activities
6-6. The score of health conditions
6-7. Individual items of the JKOM questionnaire
7. MOS Short-Form 36-Item Health Survey (SF-36)
7-1. Physical component summary (PCS)
7-2. Mental component summary (MCS)
7-3. Role/Social component summary (RCS)
7-4. Physical functioning
7-5. Role physical
7-6. Bodily pain
7-7. General health
7-8. Vitality
7-9. Social functioning
7-10. Role emotional
7-11. Mental health
8. The total score of Pittsburgh Sleep Quality Index, Japanese version (PSQI-J)
9. Specific IgE (cedar pollen, cypress pollen, Dermatophagoides pteronyssinus and house dust)

* 1-5, 7-9 Assess the measured value at screening (before consumption) and at four weeks after the start of test-food consumption and calculate the amount of change.
* 6 Measured at screening (before consumption) and at four weeks after the start of test-food consumption.


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

Duration: Four weeks
Test food: Powder containing proteoglycan
Administration: Take one pack, once a day with dinner.

* If you forget to take the test food, take it before going to bed.

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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adult subjects

2. Subjects who age between 20 and 59 when they provide written informed consent

3. Subjects between 22 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)

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

5. Subjects who have relatively high Body fat percentage at screening (before consumption)

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, 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 three months before the agreement to participate in this trial or plan to participate another trial during this trial

9. Subjects who drink alcoholic beverages immoderately

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

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

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

TEL

03-3818-0610

Email

kazu@orthomedico.jp


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

Hirosaki University Graduate School Of Medicine Microbiology and Immunology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara 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

info@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)


Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 25 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

16

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 19 Day

Date of IRB

2019 Year 11 Month 19 Day

Anticipated trial start date

2019 Year 11 Month 26 Day

Last follow-up date

2020 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 25 Day

Last modified on

2022 Year 08 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044097


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name