UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study for Reduction of Blood Lipid Peroxide, Interaction between Blood-Carotenoids and Effect on Cognitive Impairment by Ingestion of Chlorella-containing Food
Title of the study (Brief title)	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	Akira Honma
Organization	Social Welfare Service Corporation Yokufukai
Division name	Dementia Care Research and Training Center
Address	1-12-1 Takaidonishi Suginami-ku Tokyo 168-0071, Japan
TEL	03-3334-2173
Email	webmaster@yokufuukai.or.jp

Public contact
Name of contact person	TES Holdings Co., Ltd.
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015343