UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058222
Receipt number R000066518
Scientific Title Verification of blood kinetics of experimental foods
Date of disclosure of the study information 2025/06/20
Last modified on 2025/06/19 15:09:01

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Basic information

Public title

Examination of blood concentration of experimental foods after single dose

Acronym

Examination of blood concentration of experimental foods after single dose

Scientific Title

Verification of blood kinetics of experimental foods

Scientific Title:Acronym

Verification of blood kinetics of experimental foods

Region

Japan


Condition

Condition

Able-bodied person

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the vitamin C absorption kinetics of experimental foods consisting of multiple formulations in able-bodied person.

Basic objectives2

Others

Basic objectives -Others

Food absorption kinetics

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood concentration of active ingredients after ingestion of experimental foods

Key secondary outcomes

Total antioxidant capacity, Adverse events


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take 4 types of food containing active ingredients once each

Interventions/Control_2

Take 4 types of food containing active ingredients once each

Interventions/Control_3

Take 4 types of food containing active ingredients once each

Interventions/Control_4

Take 4 types of food containing active ingredients once each

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Japanese men and women aged 20 to 65 years at the time of consent
2) Healthy individuals not undergoing any treatment
3) BMI 18.5 kg/m2 or greater and less than 25.0 kg/m2
4) Able to attend designated examinations and complete records
5) Subjects who have received a full explanation of the study's purpose and contents and voluntarily agreed to participate in the study in writing

Key exclusion criteria

1) Subjects with a history of digestive problems
2) Subjects with drug or food allergies
3) Subjects with hypersensitivity to the experimental foods
4) Subjects who are pregnant or breastfeeding
5) Subjects who have had more than 200 ml of blood drawn within one month prior to the date of consent or more than 400 ml within three months
6) Subjects who drink more than 20g of alcohol per day
7) Subjects who smoke
8) Subjects who regularly use supplements and vitamin preparations (including intravenous drips/injections)
9) Subjects who cannot refrain from taking foods for specified health uses, foods with functional claims, or other so-called health foods during the study period
10) Subjects who cannot take the experimental foods as instructed
11) Subjects who work night shifts or shift work
12) Subjects with renal dysfunction
13) Subjects who are participating in other clinical trials, clinical research, or clinical studies
14) Subjects who cannot follow the instructions of the principal investigator, or who the principal investigator deems inappropriate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Soma
Middle name
Last name Ode

Organization

Macromill, Inc.

Division name

Life Science Division

Zip code

108-0075

Address

Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN

TEL

03-6716-0700

Email

ohde@macromill.com


Public contact

Name of contact person

1st name Minami
Middle name
Last name Hanaoka

Organization

Macromill, Inc.

Division name

Life Science Division

Zip code

108-0075

Address

Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN

TEL

03-6716-0700

Homepage URL


Email

m_hanaoka@macromill.com


Sponsor or person

Institute

Macromill, Inc.

Institute

Department

Personal name



Funding Source

Organization

DHC Corporation

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

Mibyou Research Ethics Review Committee

Address

2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo

Tel

03-6272-9163

Email

renraku@npo-mibyou.com


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

メディカルステーションクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2025 Year 06 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

Preinitiation

Date of protocol fixation

2025 Year 05 Month 12 Day

Date of IRB

2025 Year 06 Month 16 Day

Anticipated trial start date

2025 Year 06 Month 20 Day

Last follow-up date

2025 Year 08 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 06 Month 19 Day

Last modified on

2025 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066518