UMIN-CTR Clinical Trial

Public title

Investigation of the gene polymorphism marker to predict the effect of lactoferrin on visceral fat reduction

Acronym

Investigation of the gene polymorphism marker to predict the effect of lactoferrin on visceral fat reduction

Scientific Title

Investigation of the gene polymorphism marker to predict the effect of lactoferrin on visceral fat reduction

Scientific Title:Acronym

Investigation of the gene polymorphism marker to predict the effect of lactoferrin on visceral fat reduction

Region

Japan

Condition

No (healthy adults)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Search for new lactoferrin effect prediction gene polymorphism marker candidates that can predict visceral fat, BMI reduction effect, etc.

Basic objectives2

Others

Basic objectives -Others

Search for SNPs related to individual differences such as visceral fat and BMI reduction effect of lactoferrin

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

SNPs related to visceral fat, BMI reduction effect, etc. after 12 weeks of continuous intake of lactoferrin

Key secondary outcomes

Questionnaire about lifestyle

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Persons to be analyzed of UMIN000031545.
(2)Persons who have fully understood the purpose and contents of this test and has obtained written consent to participate in this test.

Key exclusion criteria

(1)Persons who have already participated in other clinical trials that affect lifestyle, such as diet, exercise, and sleep.
(2)Persons who are judged as unsuitable for the study by the investigator for the other reason.

Target sample size

107

Name of lead principal investigator

1st name	Yoshiyuki
Middle name
Last name	Obayashi

Organization

LION Corporation

Division name

Well-being Research Laboratories

Zip code

2560811

Address

100, Tajima, Odawara, Kanagawa, JAPAN

TEL

0465-49-4487

Email

yo-0324@lion.co.jp

Name of contact person

1st name	Yoshiyuki
Middle name
Last name	Obayashi

Organization

LION Corporation

Division name

Well-being Research Laboratories

Zip code

2560811

Address

100, Tajima, Odawara, Kanagawa, JAPAN

TEL

0465-49-4487

Homepage URL

Email

yo-0324@lion.co.jp

Institute

LION Corporation

Institute

Department

Personal name

Organization

LION Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Genequest Inc.
New drug research center, Inc.

Name of secondary funder(s)

Organization

Fukuhara Clinic Clinical Trial Review Committee

Address

3-1-15 Shimamatsu Higashimachi, Eniwa City, Hokkaido, JAPAN

Tel

0123-36-8029

Email

d-kameda@mediffom.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福原医院（北海道）（Fukuhara Clinic（Hokkaido））

Date of disclosure of the study information

2020

Year

11

Month

16

Day

URL releasing protocol

Not open to the public.

Publication of results

Published

URL related to results and publications

Not open to the public.

Number of participants that the trial has enrolled

73

Results

SNP candidates related to visceral fat and BMI reduction effect after 12 weeks continuous intake of lactoferrin were extracted.

Results date posted

2023

Year

01

Month

11

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Active n=36, Placebo n=37

Participant flow

Among the subjects for PPS analysis of UMIN study ID: UMIN000031545, after fully understanding the purpose and content of this study, their voluntary written consent to participate in this study was obtained.

Adverse events

None

Outcome measures

SNP candidates related to visceral fat and BMI reduction effect after 12 weeks continuous intake of lactoferrin were extracted.
Lifestyle candidates related to visceral fat and BMI reduction effect after 12 weeks continuous intake of lactoferrin were extracted.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

10

Month

30

Day

Date of IRB

2020

Year

10

Month

26

Day

Anticipated trial start date

2020

Year

11

Month

17

Day

Last follow-up date

2021

Year

01

Month

23

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

SNPs related to visceral fat, BMI reduction effect, etc. after 12 weeks of continuous intake of lactoferrin

Registered date

2020

Year

11

Month

16

Day

Last modified on

2023

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048482