UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043010
Receipt number R000049103
Scientific Title An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.
Date of disclosure of the study information 2021/01/16
Last modified on 2021/07/19 10:39:15

* 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

An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.

Acronym

An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.

Scientific Title

An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.

Scientific Title:Acronym

An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Plasma beta-carotene concentration (TRL fraction)

Key secondary outcomes

Plasma alpha-carotene, lycopene, lutein, zeaxanthin, beta-cryptoxanthin, total carotenoid and retinyl palmitate concentration (TRL fraction).
Plasma beta-carotene, alpha-carotene, lycopene, lutein, zeaxanthin, beta-cryptoxanthin, total carotenoid and retinyl palmitate concentration (All fraction).


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

Subjects receive a single dose of the placebo food. After the washout period (13 days or more), subjects receive a single dose of the active food (low dose). After the washout period (13 days or more), subjects receive a single dose of the active food high dose).

Interventions/Control_2

Subjects receive a single dose of the active food (low dose). After the washout period (13 days or more), subjects receive a single dose of the active food (high dose). After the washout period (13 days or more), subjects receive a single dose of the placebo food.

Interventions/Control_3

Subjects receive a single dose of the active food (high dose). After the washout period (13 days or more), subjects receive a single dose of the placebo food. After the washout period (13 days or more), subjects receive a single dose of the active food (low dose).

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

35 years-old >=

Gender

Male

Key inclusion criteria

1) Subjects giving written informed consent
2) Males aged 20 to 35 years old when consent acquisition
3) Subjects whose body mass index (BMI) is from 18.5 kg/m2 to 25.0 kg/m2

Key exclusion criteria

1) Subjects who routinely use pharmaceuticals, quasi-drugs, dietary supplement, and consume food for specified health uses, supplements containing carotenoids more than two days per week
2) Subjects who have chronic diseases necessitating treatments and/or medications
3) Subjects who have abnormal lipid metabolism, glucose metabolism, liver function, or kidney function
4) Subjects who have food allergy
5) Subjects who have lactose intolerance
6) Subjects who received digestive surgical procedures
7) Subjects who are habitual smokers within a month of study enrollment
8) Subjects who donate 200 mL of blood within a month, or 400 mL of blood within three month
9) Subjects who participate in other clinical trials within the past month or have plans to participate in other clinical trials during this study period
10) Subjects who determine ineligible by the principal investigator or sub-investigator

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Yukio
Middle name
Last name Asami

Organization

Meiji Co., Ltd.

Division name

Food Microbiology Research Laboratories, R&D Division

Zip code

192-0919

Address

1-29-1 Nanakuni, Hachiouji, Tokyo

TEL

042-632-5838

Email

yukio.asami@meiji.com


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Morifuji

Organization

Meiji Co., Ltd

Division name

Food Microbiology Research Laboratories, R&D Division

Zip code

192-0919

Address

1-29-1 Nanakuni, Hachiouji, Tokyo

TEL

042-632-5838

Homepage URL


Email

masashi.morifuji@meiji.com


Sponsor or person

Institute

Meiji Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Meiji Institutional Review Board

Address

1-29-1 Nanakuni, Hachiouji, Tokyo

Tel

042-632-5900

Email

MEIJI.IRB@meiji.com


Secondary IDs

Secondary IDs

YES

Study ID_1

20112001

Org. issuing International ID_1

CPCC Institutional Review Board

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

チヨダパラメディカルケアクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 01 Month 16 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


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 12 Month 01 Day

Date of IRB

2020 Year 11 Month 12 Day

Anticipated trial start date

2021 Year 02 Month 10 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 01 Month 15 Day

Last modified on

2021 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049103


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name