Unique ID issued by UMIN | UMIN000045518 |
---|---|
Receipt number | R000048261 |
Scientific Title | Clinical study of astaxanthin on glucose metabolism and vascular function |
Date of disclosure of the study information | 2021/09/20 |
Last modified on | 2021/09/19 13:14:32 |
Clinical study of astaxanthin on glucose metabolism and vascular function
Clinical study of astaxanthin on glucose metabolism and vascular function
Clinical study of astaxanthin on glucose metabolism and vascular function
Clinical study of astaxanthin on glucose metabolism and vascular function
Japan |
healthy volunteers including prediabetes
Adult |
Others
NO
We conduct clinical research on glucose metabolism and vascular function of astaxanthin, and examine the possibility of contributing to health promotion and extension of healthy life expectancy, such as prevention of diabetes in the general population.
Efficacy
Others
Others
Not applicable
HbA1c
75g OGTT,RHI,Lipids
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Food |
Astaxanthin 12 mg daily for 12 weeks
placebo for 12 weeks
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Those whose fasting blood glucose is 125 mg / dL or less.
2) Those who can take astaxanthin for 3 months.
3) Those who are between the ages of 20 and 75 at the time of obtaining consent.
4) Those who have received sufficient explanation before participating in this research, and who have obtained the consent of the document by their own free will after sufficient understanding.
5) Those who can be inspected outpatiently.
6) Those who have not taken other health foods or supplements that affect the evaluation of astaxanthin efficacy within one month before the start of the study.
1) Those who have been diagnosed with diabetes or who have been diagnosed with diabetes.
2) Women who are pregnant or may be pregnant, women who wish to become pregnant, and
Lactating woman.
3) Those who are receiving drug therapy at a medical institution.
4) In addition, those who are judged to be inappropriate for this study by the clinical research investigator or the co-investigator.
60
1st name | Masahiro |
Middle name | |
Last name | Toshima |
Kamiichi General Hospital
vascular surgery
930-0391
51 Hoonji, Kamiichi-machi, Nakaniikawa-gun, Toyama Prefecture
076-472-1212
murakaze@kamiichi-hosp.jp
1st name | Masaharu |
Middle name | |
Last name | Urakaze |
Kamiichi General Hospital
Medicine
930-0391
51 Hoonji, Kamiichi-machi, Nakaniikawa-gun, Toyama Prefecture
076-472-1212
murakaze@kamiichi-hosp.jp
Kamiichi General Hospital
The Small and Medium Enterprise Agency
Japanese Governmental office
Fuji Chemical Industries Co.,Ltd.
Japan Society of Nutrition & Food Science
3-60-5 Ikebukuro, Toshima-ku, Tokyo
03-6902-0072
eishokujimu@jsnfs.or.jp
NO
かみいち総合病院(富山県)
2021 | Year | 09 | Month | 20 | Day |
https://diabetes.diabetesjournals.org/content/67/Supplement_1/766-P
Partially published
https://diabetes.diabetesjournals.org/content/67/Supplement_1/766-P
53
After ASTX (12mg/day) supplementation for 12 weeks, the glucose level at 30 min by 75g OGTT was significantly decreased compared to before. The level of HbA1c was also significantly decreased compared to before.
2021 | Year | 09 | Month | 19 | Day |
Fifty-three patients were enrolled in the study, and 44 of them (male 15, female 29) completed the study. Average age was about 47 years old
Each participant was required to ingest one tablet of either the placebo or the ASTX supplement daily for 12 weeks. The daily ingestion amount of 12 mg and ingestion period of 12 weeks were set. Blood samples were collected before and after 12 weeks of supplementation with ASTX or placebo after overnight fasting. At each 4 week visit, participants' adherence to the study protocol was assessed by counting the remaining tablets. Participants were also asked to maintain their habitual diet, lifestyle and tablet ingestion.
no noteworthy adverse effects
Glucose tolerance test, HbA1c, total cholesterol, HDL cholesterol, triglycerides, RLP cholesterol, oxidized LDL, apolipoprotein
Completed
2015 | Year | 10 | Month | 29 | Day |
2015 | Year | 11 | Month | 20 | Day |
2015 | Year | 12 | Month | 01 | Day |
2016 | Year | 06 | Month | 30 | Day |
2021 | Year | 09 | Month | 19 | Day |
2021 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048261
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |