UMIN-CTR Clinical Trial

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
Institute	Kamiichi General Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048261