UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the effects of ingestion of collagen octapeptide (Gly-Ala-Hyp-Gly-Leu-Hyp-Gly-Pro) on endothelial function in healthy adult with lower endothelial function.
Title of the study (Brief title)	A study for the effects of ingestion of collagen octapeptide on endothelial function in healthy adult.
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of endothelial function and safety of ingestion of collagen octapeptide (Gly-Ala-Hyp-Gly-Leu-Hyp-Gly-Pro) for 8 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Flow Mediated Dilation (FMD)
Key secondary outcomes	Fatigue sensation (VAS) Athens Insomnia Scale Pittsburgh Sleep Quality Index

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are 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	Ingestion of collagen octapeptide (Gly-Ala-Hyp-Gly-Leu-Hyp-Gly-Pro) for 8 weeks.
Interventions/Control_2	Ingestion of placebo for 8 weeks.
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy adult who aged 20-64 years old. (2) FMD value 4.0-7.0% (3) BMI less than 25.0 kg/m 2
Key exclusion criteria	(1) Subjects who take pharmaceutical agent, functional food, or supplement that may affect the study. (2) Subjects who routinely use food rich in collagen. (3) Ineligible subjects with abnormal laboratory value or cardiopulmonary function. (4) Subjects having possibilities for emerging allergy related to the study. (5) Subjects who are under medication. (6) Subjects who are under treatment or have a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease). (7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. (8) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work and overseas. (9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (10) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (12) Subjects who cannot obey the restriction item (prohibited matter) during the study. (13) Subjects who are hypertension stage I (SBP>=140 mmHg and/or DBP>=90 mmHg). (14) Subjects who have baPWV value 1400 cm/s or more. (15) Subjects judged as unsuitable for the study by the investigator for other reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	Mihoko Kurokawa
Organization	Q'SAI CO., LTD.
Division name	Research and Development Department
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	Shingo Yamamichi
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.yamamichi@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)

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 02 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 31 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035486