UMIN-CTR Clinical Trial

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

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Basic information

Public title

Clinical study of astaxanthin on glucose metabolism and vascular function

Acronym

Clinical study of astaxanthin on glucose metabolism and vascular function

Scientific Title

Clinical study of astaxanthin on glucose metabolism and vascular function

Scientific Title:Acronym

Clinical study of astaxanthin on glucose metabolism and vascular function

Region

Japan


Condition

Condition

healthy volunteers including prediabetes

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

HbA1c

Key secondary outcomes

75g OGTT,RHI,Lipids


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Astaxanthin 12 mg daily for 12 weeks

Interventions/Control_2

placebo for 12 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

75 years-old >

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Toshima

Organization

Kamiichi General Hospital

Division name

vascular surgery

Zip code

930-0391

Address

51 Hoonji, Kamiichi-machi, Nakaniikawa-gun, Toyama Prefecture

TEL

076-472-1212

Email

murakaze@kamiichi-hosp.jp


Public contact

Name of contact person

1st name Masaharu
Middle name
Last name Urakaze

Organization

Kamiichi General Hospital

Division name

Medicine

Zip code

930-0391

Address

51 Hoonji, Kamiichi-machi, Nakaniikawa-gun, Toyama Prefecture

TEL

076-472-1212

Homepage URL


Email

murakaze@kamiichi-hosp.jp


Sponsor or person

Institute

Kamiichi General Hospital

Institute

Department

Personal name



Funding Source

Organization

The Small and Medium Enterprise Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Fuji Chemical Industries Co.,Ltd.


IRB Contact (For public release)

Organization

Japan Society of Nutrition & Food Science

Address

3-60-5 Ikebukuro, Toshima-ku, Tokyo

Tel

03-6902-0072

Email

eishokujimu@jsnfs.or.jp


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

かみいち総合病院(富山県)


Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 20 Day


Related information

URL releasing protocol

https://diabetes.diabetesjournals.org/content/67/Supplement_1/766-P

Publication of results

Partially published


Result

URL related to results and publications

https://diabetes.diabetesjournals.org/content/67/Supplement_1/766-P

Number of participants that the trial has enrolled

53

Results

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.

Results date posted

2021 Year 09 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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

Participant flow

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.

Adverse events

no noteworthy adverse effects

Outcome measures

Glucose tolerance test, HbA1c, total cholesterol, HDL cholesterol, triglycerides, RLP cholesterol, oxidized LDL, apolipoprotein

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 10 Month 29 Day

Date of IRB

2015 Year 11 Month 20 Day

Anticipated trial start date

2015 Year 12 Month 01 Day

Last follow-up date

2016 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 09 Month 19 Day

Last modified on

2021 Year 09 Month 19 Day



Link to view the page

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