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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026172
Receipt No. 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

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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 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
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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

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 3
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 75

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
Institute TTC CO., LTD.
Institute
Department

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
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
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
URL(English) https://upload.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


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