UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000026172
Receipt number	R000030074
Scientific Title	Effects of chicken collagen hydrolysate on blood pressure and endothelial function in subjects with high-normal blood pressure or stage I hypertension: a randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information	2017/10/08
Last modified on	2017/11/17 09:17:23

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Basic information

Public title

Effects of chicken collagen hydrolysate on blood pressure and endothelial function in subjects with high-normal blood pressure or stage I hypertension: a randomized, double-blind, placebo-controlled, parallel-group study

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To investigate the effectiveness and safety of chicken collagen hydrolysate intake for 12 weeks improve hypertension and endothelial function

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Changes of flow-mediated dilatation (FMD), blood pressure at 4, 8, 12 weeks after the intervention.

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Chicken collagen hydrolysate (high dose)
(2.9 g(3.4 g/sachet)/day, weeks 12 during the intervention)

Interventions/Control_2

Chicken collagen hydrolysate (low dose)
(1.7 g(3.4 g/sachet)/day, weeks 12 during the intervention)

Interventions/Control_3

Placebo
3.4 g/sachet/day, weeks 12 during the intervention)

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Adult (aged 20-65)
2) Subjects with high-normal blood pressure or mild hypertension (according to guidelines for the management of hypertension 2014)
3) Subjects with low FMD value

Key exclusion criteria

1) Taking pharmaceutical agent, functional food, or supplement that may affect the study
2) Ineligible subjects with abnormal laboratory value or
cardiopulmonary function
3) Sensitive to test product or other foods
4) In treatment
5) History of severe diseases (diabetes, liver, kidney, heart (especially coronary artery disease, heart failure)) judged to be inappropriate for this study
6) Extreme deviations from the reference range of anthropometrics, physical examination or laboratory value
7) Change of life style during the test period (ex. a night shift, going abroad) may affect the study.
8) Participation in any other clinical trial within 30 days before the study.
9) In pregnancy or lactating
10) Ineligible subjects for the study according to the judgement by lifestyle questionnaire
11) Unlikely to obey the restriction item (prohibited matter) during the study
12) Ineligible subjects for the study according to the judgement by chief investigator

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Mihoko Kurokawa

Organization

Q'SAI CO., LTD.

Division name

Research Department

Zip code

Address

1-7-16 Kusagae, Chuo-ku, Fukuoka-shi, Japan 810-8606

TEL

092-724-0855

Email

kurokawa@kyusai.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Saki Fukuchi

Organization

TTC CO., LTD.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2 Ebisunishi, Shibuya-ku, Tokyo JAPAN

TEL

03-5459-5329

Homepage URL

Email

s.fukuchi@ttc-tokyo.co.jp

Sponsor or person

Institute

TTC CO., LTD.

Institute

Department

Personal name

Funding Source

Organization

Q'SAI 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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 08 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

Main results already published

Date of protocol fixation

2016 Year 03 Month 10 Day

Date of IRB

Anticipated trial start date

2016 Year 06 Month 23 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

2017 Year 02 Month 16 Day

Last modified on

2017 Year 11 Month 17 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030074

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name