UMIN-CTR Clinical Trial

Public title

Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study-

Acronym

Effect of 12-week continuous ingestion of the supplement on liver function.

Scientific Title

Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study-

Scientific Title:Acronym

Effect of 12-week continuous ingestion of the supplement on liver function.

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of 12 weeks continuous ingestion of trial supplement on liver function.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

ALT : Alanine Aminotransferase

Key secondary outcomes

AST : Aspartate Aminotransferase
Gamma-GTP : Gamma-Glutamic Transpeptidase

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test food(Intake period:12 weeks)

Interventions/Control_2

Control food (Intake period:12 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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Male and female aged between 20 to 64 years old at the time of informed consent.
2.Subjects whose BMI is between the range of 25 and 29 kg/m2.
3.Subjects whose ALT is between 31 to 50 U/+-10% at the time of the screening test 1.
4.Subjects whose ALT is between 31 to 50 U/L+-10% at the time of the screening test 2.
5.Subjects who agree to participate in the study on one's own will.

Key exclusion criteria

1.Subjects whose AST is above 50 U/L and/or Gamma-GTP above 100 U/L at the time of the screening test 2.
2.Subjects who have history of liver disease, or is currently under medical treatment of the liver disease.
3.Subjects who are suffering or suffered from serious disease in the past.
4.Subjects who have average intake of alcohol more than 59 g per week.
5.Subjects who have food allergies or who may be allergic to the test food.
6.Subjects who are taking drugs and quasi-drugs that may affect the current study.
7.Subjects who are taking health foods that may affect the current study.
8.Subjects who cannot stop taking the drugs, quasi-drugs and health foods during the study period (after agreeing to the informed consent until the end of the 12-week test food ingestion period).
9.Subjects who have extremely irregular lifestyles.
10.Subjects who are currently participating in other studies, or participating in other studies within the past 3 months from the time of the informed consent.
11.Subjects who are planning to participate in other studies during this study.
12.Subjects who are pregnant, or planning to become pregnant or breastfeed during this study.
13.Subjects who are judged as unsuitable participant for the study by the doctor and investigator.

Target sample size

100

Name of lead principal investigator

1st name	Kei
Middle name
Last name	Yui

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

244-0806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan

TEL

045-820-3755

Email

ke-yui@fancl.co.jp

Name of contact person

1st name	Eiji
Middle name
Last name	Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL

Email

eigyou27@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Nihonbashi Cardiology Clinic

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

Tel

03-5641-4133

Email

niho-jimucho@well-sleep.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人財団健康睡眠会　日本橋循環器科クリニック

Date of disclosure of the study information

2021

Year

06

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

100

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

Recruitment status

Completed

Date of protocol fixation

2021

Year

05

Month

11

Day

Date of IRB

2021

Year

04

Month

06

Day

Anticipated trial start date

2021

Year

06

Month

12

Day

Last follow-up date

2021

Year

11

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

06

Month

10

Day

Last modified on

2022

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050832