UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018070 |
|---|---|
| Receipt number | R000020917 |
| Scientific Title | Effect of ingestion of supplement containing astaxanthin and trans-resveratrol on the serum triglyceride level -A randomized, double-blind, placebo controlled and parallel group study- |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/05/31 13:45:04 |
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Basic information
Public title
Effect of ingestion of supplement containing astaxanthin and trans-resveratrol on the serum triglyceride level -A randomized, double-blind, placebo controlled and parallel group study-
Acronym
Effect of ingestion of supplement containing astaxanthin and trans-resveratrol on the level of serum triglyceride
Scientific Title
Effect of ingestion of supplement containing astaxanthin and trans-resveratrol on the serum triglyceride level -A randomized, double-blind, placebo controlled and parallel group study-
Scientific Title:Acronym
Effect of ingestion of supplement containing astaxanthin and trans-resveratrol on the level of serum triglyceride
Region
| Japan |
Condition
Condition
None (Main subjects with Slightly higher serum triglyceride level (120 to 200 mg/dL))
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effect of ingestion of the supplement containing astaxanthin and trans-resveratrol for consecutive weeks on the level of serum triglyceride of the volunteer aged 40 to 64 years with slightly higher serum triglyceride level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variations from the baseline of serum triglyceride level
Key secondary outcomes
Variations from the baseline of adiponectin, high molecular weight adiponectin, inflammation markers (TNF-alpha, high sensitive CRP), non-esterified fatty acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, or nonHDL-cholesterol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of supplement containing astaxanthin and trans-resveratrol for 12 weeks
Interventions/Control_2
Ingestion of placebo without astaxanthin and trans-resveratrol 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females from 40 to 64 years of age at the time of the informed consent
2) Slightly higher level of serum triglyceride
(The main subjects have 120 mg/dL to 199 mg/dL of serum triglyceride level.)
Key exclusion criteria
1) Subjects who have history of hyperlipidemia and have been by treatment hyperlipidemia with present or the last one year
2) Subjects who are under medication or are judged to that medical treatment are necessary by the medical doctor
3) Subjects who have a history of diabetes, liver disease, kidney disease, and/or adrenal cortex disease
4) Subjects who routinely use medicine (including over-the-counter medicine), Food for Specified Health Uses, Food with function claims, health food
5) Subjects who routinely eat fish as main dish for 5 days per a week
6) Subjects with above BMI 30 kg/m^2
7) Subjects with Hormone-responsive disease (e.g., uterine leiomyoma, endometriosis)
8) Subjects who are under dieting (or weight loss)
9) Subjects who are planned to change their life style
10) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
11) Subject who have participated in other clinical study within the last one month prior to the current study
12) Subject who are judged as unsuitable for the study by the investigator for other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuriko Mizobe |
Organization
Yaesu Sakuradori Clinic
Division name
Internal medicine
Zip code
Address
1-6-6yaesu,chuo-ku,Tokyo,Japan
TEL
03-6214-1285
info@y-sakuradoori.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Shimizu |
Organization
FANCL CORPORATION
Division name
Research institute
Zip code
Address
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3522
Homepage URL
shimizu_yoshiki@fancl.co.jp
Sponsor or person
Institute
FANCL CORPORATION
Institute
Department
Personal name
Funding Source
Organization
FANCL CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人社団 桜緑会 八重洲さくら通りクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 24 | Day |
Last modified on
| 2016 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020917
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