UMIN-ICDS Clinical Trial

Public title

The verification study for Genetic polymorphism marker predict the efficacy of lactoferrin

Acronym

The verification study for Genetic polymorphism marker predict the efficacy of lactoferrin

Scientific Title

The verification study for Genetic polymorphism marker predict the efficacy of lactoferrin -Open-Label study-

Scientific Title:Acronym

The verification study for Genetic polymorphism marker predict the efficacy of lactoferrin

Region

Japan

Condition

Healthy subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Verification of candidate polymorphic markers of lactoferrin that can predict the effect of lactoferrin intake on abdominal visceral fat area and BMI reduction, and verification of model equations that can predict the effect of lactoferrin intake on abdominal visceral fat area and BMI reduction utilizing these candidate polymorphic markers.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

SNPs associated with the effect of lactoferrin intake on abdominal visceral fat area or BMI reduction and model equations for predicting the effect of lactoferrin using these SNPs.

Key secondary outcomes

1) Lifestyle habits associated with the effect of lactoferrin intake on reducing abdominal visceral fat area/BMI and the model equation for predicting the effect using these habits
2) SNPs and lifestyle habits associated with the effect of lactoferrin intake on reducing abdominal visceral fat area/BMI, and the model equation for predicting the effect using these SNPs and lifestyle habits
3) SNPs and lifestyle habits associated with the effect of lactoferrin intake on reducing abdominal subcutaneous fat area/total abdominal fat area, and model equations for predicting effect using these SNPs and lifestyle habits.
4) SNPs associated with the effects of lactoferrin intake on waist circumference/hip circumference/total cholesterol/LDL-cholesterol/HDL-cholesterol/TG (triglycerides)/glucose/systolic blood pressure/ diastolic blood pressure, and the model equations for predicting the effects using these SNPs.
5) Abdominal visceral fat area, abdominal subcutaneous fat area, and total abdominal fat area
6) BMI
7) Waist circumference and hip circumference
8) Total cholesterol, LDL-cholesterol, HDL-cholesterol, TG (triglycerides), and glucose
9) Systolic blood pressure and diastolic blood pressure
10) Body composition

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

300 mg of enteric-coated lactoferrin once daily for 8 weeks

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

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

･Those who are between 20 and 65 years of age at the time of obtaining consent to participate in the research.
･Japanese nationals (excluding naturalized citizens or those who have naturalized citizens or foreign nationals up to the second degree of kinship), men and women who are not related by blood (up to the second degree of kinship) within the research subjects.
･BMI of 25 or higher at the time of screening test.
･Abdominal visceral fat area of 80 cm² or more at the time of screening.
･Those who are able to come to the research institution on the scheduled visit date.
･Those who are able to abstain from alcohol consumption from the day before the screening test and 8 weeks after the intake test.
･Those who have been fully informed of the purpose and content of the research, have the capacity to consent, and who have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research, and who have agreed to participate in the research in writing.

Key exclusion criteria

･Those who are determined to be in the therapeutic area by the interview of the principal investigator and researcher at the time of screening test.
･Those who are scheduled to receive medication or undergo surgery due to a serious illness or injury within one month prior to the start of the research ).
･Those who have a history of serious illness or current illness in the heart, liver, kidney, digestive organs, etc.
･Those who have difficulty in collecting 2 mL of saliva due to Sjogren's syndrome, dry mouth, etc.
･Those who use or consume medicines, supplements or health foods that may affect dyslipidemia, obesity, etc.
･Persons taking medications that suppress salivary secretion.
･Persons who are regularly taking over-the-counter drugs, foods for specified health uses, foods with functional claims, nutritional foods, etc. that may affect the research.
･Pregnant or possibly pregnant or lactating women who may become pregnant during the study period.
･Heavy alcohol drinkers and excessive smokers.
･Persons who have experienced illness or physical discomfort due to blood sampling in the past.
･Have donated or will donate 400 mL blood within 12 weeks, 200 mL blood within 4 weeks, or component blood within 2 weeks prior to the screening test.
･Constipation.
･Those with extremely irregular eating habits.
･Those who have business trips or travel on average 10 days or more per month.
･Persons who have or may have milk allergy.
･Persons who have metal in the CT scan measurement site.
･Persons with implantable medical devices.
･Persons with claustrophobia, skin diseases, or metal allergies.
･Those who have already participated in other studies or will participate in other studies during the period of this study.
･Those who do not agree with the purpose of the explanation of this research conducted beforehand.
･Other subjects who are deemed inappropriate as research subjects by the principal investigator or the researcher.

Target sample size

80

Name of lead principal investigator

1st name	Yoshiyuki
Middle name
Last name	Obayashi

Organization

LION Corporation

Division name

Well-being Research Laboratories

Zip code

256-0811

Address

100, Tajima, Odawara, Kanagawa, JAPAN

TEL

0465-49-4487

Email

yo-0324@lion.co.jp

Name of contact person

1st name	Tomoji
Middle name
Last name	Ono

Organization

LION Corporation

Division name

Advanced Analytical Science Research Laboratories

Zip code

132-0035

Address

7-2-1, Hirai, Edogawa-ku, Tokyo, JAPAN

TEL

03-3616-3646

Homepage URL

Email

tomoono@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.
KSO Corporation

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

311-2, Gokan-cho, Maebashi, Gunma, JAPAN

Tel

027-261-7600

Email

sagawa@mc-connect.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

一般財団法人船員保険会　品川シーズンテラス健診クリニック（東京都）

Date of disclosure of the study information

2023

Year

05

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

No longer recruiting

Date of protocol fixation

2023

Year

02

Month

09

Day

Date of IRB

2023

Year

02

Month

08

Day

Anticipated trial start date

2023

Year

05

Month

29

Day

Last follow-up date

2023

Year

10

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

05

Month

09

Day

Last modified on

2023

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058155