UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040821
Receipt number R000046600
Scientific Title The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.
Date of disclosure of the study information 2020/06/26
Last modified on 2021/04/15 14:37:20

* 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

The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.

Acronym

The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.

Scientific Title

The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.

Scientific Title:Acronym

The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the improving effects and safety on neutral fat, liver fat and uric acid level by ingesting the test food for 12 weeks in healthy males and females aged from 20 to 65 years old.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Neutral fat

Key secondary outcomes

Liver-spleen ratio
Physical examination: body weight, body fat percentage, BMI, waist circumference
, gamma-GTP, creatinine, HbA1c, glucose,
Insulin, TC, HDL-C, LDL-C, uric acid
questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take 3 tablets of the test food (low dose) daily with water or hot water.

Interventions/Control_2

Take 3 tablets of the test food(high dose) daily with water or hot water.

Interventions/Control_3

Take 3 tablets of placebo daily with water or hot water.

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. 20 to 64 years old (at the time of submission of an informed consent document).
2. Japanese male and female.
3. BMI of 23.0kg/m2 to <30.0kg/m2
4. Neutral fat of <200mg/dL
5. Smartphone or PC users (who can input their own data into the electronic diary).
6. Those who do not plan to change their daily habits during the examination period.
7. Those who can provide their written informed consent.

Key exclusion criteria

1. Those who are currently receiving any types of medicines and/or Chinese medical treatment (except for the medication needed).
2. Those who have or had a severe disease of the liver, kidney, heart, respiratory, endocrine and metabolic diseases.
3. Those who are treated for the dyslipidemia or hyperuricemia.
4. Those who have undergone gastrointestinal surgery (appendicitis acceptable).
5. Those who have been routinely taking foods for specified health use, health foods with functional claims or supplements, which are expected to improve body fat reduction or lipid metabolism-related test values and uric acid levels.
6. Those who cannot abstain from taking health food other than test food during the test period.
7. Those who have a current or previous history of drug and/or food allergies.
8. Heavy drinkers.
9. Those who have metals implanted in the body due to surgery etc.
10. Those who have a cardiac pacemaker or an implantable medical device placed in the body.
11. Those who have claustrophobia.
12. Those who work night shifts.
13. Those who are currently undergoing treatment for drug dependence or drug abuse or those who have a past medical history of either of htem.
14. Those who have collected or donated more than 200mL within 1 month or 400mL within 3 months of the pre-examination.
15. Those who are surrently pregnant or breastfeeding or those who want to become pregnant during the study period.
16. Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
17. Those who were determined by the principal investigator and the sub investigator to be unsuitable for participation in this clinical trial.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hiroyasu
Middle name
Last name Sugimoto

Organization

HOSODA SHC Co., Ltd.

Division name

Health care Dept.

Zip code

910-0854

Address

3-2-21 Miyuki, Fukui City, Fukui

TEL

0776-22-4748

Email

h-sugimoto@hosoda-shc.co.jp


Public contact

Name of contact person

1st name Hirokuni
Middle name
Last name Kayama

Organization

IMEQRD Co., Ltd

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL


Email

n-yuzawa@imeqrd.co.jp


Sponsor or person

Institute

IMEQRD Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

HOSODA SHC Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-6704-5968

Email

n-yuzawa@imeqrd.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 06 Month 26 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

60

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 05 Month 28 Day

Date of IRB

2020 Year 05 Month 29 Day

Anticipated trial start date

2020 Year 08 Month 15 Day

Last follow-up date

2021 Year 01 Month 16 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 06 Month 18 Day

Last modified on

2021 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046600


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name