UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030891
Receipt number R000035253
Scientific Title An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products
Date of disclosure of the study information 2018/01/20
Last modified on 2018/04/13 08:49:54

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Basic information

Public title

An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products

Acronym

An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products

Scientific Title

An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products

Scientific Title:Acronym

An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the enhancing effect of the absorption of nutrients by consumption of dairy products

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Plasma beta-carotene level

Key secondary outcomes

Plasma lycopene, lutein, alpha-carotene, zeaxanthin levels


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

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects consume the active food once a day. After the washout period (from 13 days to 20 days), subjects consume the placebo food once a day.

Interventions/Control_2

Subjects consume the placebo food once a day. After the washout period (from 13 days to 20 days), subjects consume the active food once a day.

Interventions/Control_3


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, food for specified health uses, supplements containing carotenoids more than two days per week, or during this study period
2)Subjects who have chronic diseases and administer treatments and 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 operated digestive surgical.
7) Subjects who habitually smoke within a month
8) Subjects who participated in other clinical trials within a month or plan to participate other clinical trials during this study period
9) Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Asami

Organization

Meiji Co., Ltd.

Division name

Food Microbiology Research Laboratories, R&D Division

Zip code


Address

1-29-1 Nanakuni, Hachiouji, Tokyo

TEL

042-632-5822

Email

yukio.asami@meiji.com


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyuki Fukasawa

Organization

Meiji Co., Ltd.

Division name

Food Microbiology Research Laboratories, R&D Division

Zip code


Address

1-29-1 Nanakuni, Hachiouji, Tokyo

TEL

042-632-5822

Homepage URL


Email

tomoyuki.fukasawa@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


Address


Tel


Email



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

2018 Year 01 Month 20 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

2017 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 19 Day

Last modified on

2018 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035253


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name