UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013754 |
|---|---|
| Receipt number | R000015343 |
| Scientific Title | A Study for Reduction of Blood Lipid Peroxide, Interaction between Blood-Carotenoids and Effect on Cognitive Impairment by Ingestion of Chlorella-containing Food |
| Date of disclosure of the study information | 2014/04/18 |
| Last modified on | 2016/08/26 16:20:18 |
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Basic information
Public title
A Study for Reduction of Blood Lipid Peroxide, Interaction between Blood-Carotenoids and Effect on Cognitive Impairment by Ingestion of Chlorella-containing Food
Acronym
A Study for Reduction of Blood Lipid Peroxide, Interaction between Blood-Carotenoids and Effect on Cognitive Impairment by Ingestion of Chlorella-containing Food
Scientific Title
A Study for Reduction of Blood Lipid Peroxide, Interaction between Blood-Carotenoids and Effect on Cognitive Impairment by Ingestion of Chlorella-containing Food
Scientific Title:Acronym
A Study for Reduction of Blood Lipid Peroxide, Interaction between Blood-Carotenoids and Effect on Cognitive Impairment by Ingestion of Chlorella-containing Food
Region
| Japan |
Condition
Condition
Improvement of cognitive impairment
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate cognitive impairment by ingestion of chlorella-containing food (test subjects are healthy Japanese males and females aged over 60 years). We also examine the migration of cartenoids (e.g. lutein and beta-carotene) to blood plasma and red blood cell and evaluate reduction for blood lipid peroxide by ingestion of chlorella-containg food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood lipid peroxide
Cognitive impairment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test product (12 months)
Interventions/Control_2
Oral ingestion of the control product (12 months)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged over 60 years
2)Individuals who sign the consent document after explanation of this study
3)Individuals whose total score of Japanese version of Montreal Cognitive Assessment (MoCA-J) is under 25 points
4)Individuals whos level of plasma phosphatidylcholine hydroperoxide is relatively high value
Key exclusion criteria
1) Individuals judged inappropriate for the study by the principal investigator
2) Individuals who routinely take proprietary drugs and health foods including beverages (chlorella foods, carotenoids and other products professing to improve lipid absorption and metabolic function)
3) Individuals who take lipid metabolism improver (e.g. ethyl icosapentate, statin, fibrate, anion exchange resin and ezetimibe)
4) Individuals who take warfarin
5) Individuals who take anti-dementia drugs, antidepressant drugs, antipsychotic drugs and anti-anxiety drugs
6) Individuals who excessively take alcohol and tobacco
7) Individuals who are sensitive to medical products and cosmetics
8) Individuals who participated in other clinical studies
9) Individuals who have anamnesis or history of present illness of head injury, cerebral stroke and epilepsia
10) Individuals who have serious hepatopathy, kidney damage and heart disease
11) Individuals whose observed data of GT is over 300mg/dL
12) Individuals whose observed data of gamma-GTP is over 2 times of upper value (male: 75 U/L, female: 45 U/L)
13) Individuals whose observed data of AST is over 2 times of upper value (male and female: 40 U/L)
14) Individuals whose observed data of ALT is over 2 times of upper value (male and female: 45 U/L)
15) Individuals whose observed data of SCR is over 2.0mg/dL
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Honma |
Organization
Social Welfare Service Corporation Yokufukai
Division name
Dementia Care Research and Training Center
Zip code
Address
1-12-1 Takaidonishi Suginami-ku Tokyo 168-0071, Japan
TEL
03-3334-2173
webmaster@yokufuukai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TES Holdings Co., Ltd. |
Organization
TES Holdings Co., Ltd.
Division name
Department of Clinical Trial
Zip code
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan
TEL
03-6801-8480
Homepage URL
info@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sun Chlorella Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Qol Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
PMS-2013-001(CL01)
Org. issuing International ID_1
Qol Co., Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人財団同仁記念会明和病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 18 | 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
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 18 | Day |
Last modified on
| 2016 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015343
