Unique ID issued by UMIN | UMIN000031071 |
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Receipt number | R000035486 |
Scientific Title | 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. |
Date of disclosure of the study information | 2018/02/02 |
Last modified on | 2018/10/29 13:47:40 |
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.
A study for the effects of ingestion of collagen octapeptide on endothelial function in healthy adult.
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.
A study for the effects of ingestion of collagen octapeptide on endothelial function in healthy adult.
Japan |
None
Not applicable | Adult |
Others
NO
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.
Safety,Efficacy
Flow Mediated Dilation (FMD)
Fatigue sensation (VAS)
Athens Insomnia Scale
Pittsburgh Sleep Quality Index
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of collagen octapeptide (Gly-Ala-Hyp-Gly-Leu-Hyp-Gly-Pro) for 8 weeks.
Ingestion of placebo for 8 weeks.
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(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
(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.
50
1st name | |
Middle name | |
Last name | Mihoko Kurokawa |
Q'SAI CO., LTD.
Research and Development Department
1-7-16 Kusagae, Chuo-ku, Fukuoka-shi, Japan 810-8606
092-724-0855
kurokawa@kyusai.co.jp
1st name | |
Middle name | |
Last name | Shingo Yamamichi |
TTC Co.,Ltd
Clinical Research Planning Department
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
s.yamamichi@ttc-tokyo.co.jp
TTC Co.,Ltd
Q'SAI CO., LTD.
Profit organization
NO
2018 | Year | 02 | Month | 02 | Day |
Unpublished
Completed
2018 | Year | 01 | Month | 25 | Day |
2018 | Year | 02 | Month | 03 | Day |
2018 | Year | 01 | Month | 31 | Day |
2018 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035486
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