UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042521
Receipt number R000048541
Scientific Title An investigation of collagen absorption: a randomized, double-blind, placebo-controlled, crossover trial.
Date of disclosure of the study information 2020/11/24
Last modified on 2021/01/07 19:13:46

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Basic information

Public title

An investigation of collagen absorption: a randomized, double-blind, placebo-controlled, crossover trial.

Acronym

An investigation of collagen absorption

Scientific Title

An investigation of collagen absorption: a randomized, double-blind, placebo-controlled, crossover trial.

Scientific Title:Acronym

An investigation of collagen absorption

Region

Japan


Condition

Condition

Healthy Japanese adult people

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of the intake of test food on collagen absorption on healthy Japanese adult subjects

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Blood hydroxyproline AUC and Cmax

*Collected serum at baseline, 30, 60, 120, and 180 minutes after intake.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: single dose
Test food: active food and placebo food
Administration: Eat test food with water during meal

I. Eat the prescribed diet with placebo food for breakfast.
II. Eat the prescribed diet with active food for breakfast.

*The intervention sequence is I-II.
*Washout period is for 4 days and more.

Interventions/Control_2

Duration: single dose
Test food: active food and placebo food
Administration: Eat test food with water during meal

I. Eat the prescribed diet with active food for breakfast.
II. Eat the prescribed diet with placebo food for breakfast.

*The intervention sequence is I-II.
*Washout period is for 4 days and more.

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

23 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Japanese adult male and female

Key exclusion criteria

1. A medical history of malignant tumor, heart failure or myocardial infarction.

2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus.

3. Subjects who are allergic to the test food related products.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Motoko
Middle name
Last name Ohnishi

Organization

Chubu University

Division name

College of Bioscience and Biotechnology

Zip code

487-8501

Address

1200 Matsumoto-cho, Kasugai-city, Aichi, JAPAN

TEL

0568-51-6328

Email

mohnishi@isc.chubu.ac.jp


Public contact

Name of contact person

1st name Daiki
Middle name
Last name Suehiro

Organization

San-ei Sucrochemical Co., Ltd.

Division name

Research and Development Section

Zip code

478-8503

Address

24-5, Kitahama-machi, Chita-city, Aichi, JAPAN

TEL

0562-55-5197

Homepage URL


Email

daiki-suehiro@sanei-toka.co.jp


Sponsor or person

Institute

Chubu University

Institute

Department

Personal name



Funding Source

Organization

San-ei Sucrochemical 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

Chubu University Certified Review Board

Address

1200 Matsumoto-cho, Kasugai-city, Aichi, JAPAN

Tel

0568-51-1141

Email

***@office.chubu.ac.jp


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

中部大学(愛知県)
Chubu University (Aichi)


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 24 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 07 Month 08 Day

Date of IRB

2020 Year 07 Month 17 Day

Anticipated trial start date

2020 Year 11 Month 24 Day

Last follow-up date

2021 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 23 Day

Last modified on

2021 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048541


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name