Condition category
Not Applicable
Date applied
26/06/2012
Date assigned
01/08/2012
Last edited
28/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof (Associate) Kiyotaka Nakagawa

ORCID ID

Contact details

1-1 Tsutsumidori-Amamiyamachi Aoba-ku Sendai
Miyagi
981-8555
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HR-2010-YH03

Study information

Scientific title

Amyloid β levels in human red blood cells: a randomized controlled trial

Acronym

Study hypothesis

Therapeutic application of astaxanthin as an Aβ-lowering agent in red blood cells (RBCs) could be considered as a possible anti-dementia agent.

Ethics approval

Ethical Committee of TES Holdings,17th May 2010, ref: 2010-04

Study design

Randomized double-blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Astaxanthin supplementation study

Intervention

1. Higher astaxanthin content group: Ingesting supplement containing 1mg astaxanthin
2. Lower astaxanthin content group: Ingesting supplement containing 3mg astaxanthin
3. Control group: placebo

Total duration of investigation was 12 weeks

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Biological Antioxidant Potential (BAP) test
2. Determination of Reactive Oxygen Metabolites (d-ROMs) test

Measured at Visit 1: Screening, Visit 2: Week 1, Visit 3: Weeks 4, Visit 4: Weeks 12

Secondary outcome measures

Peroxidized phospholipid measured at Visit 1: Screening, Visit 2: Week 1, Visit 3: Weeks 4, Visit 4: Weeks 12

Overall trial start date

01/06/2010

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female, aged 20-69 years
2. Blood Test Value: Total Cholesterol: 200-260mg/dL or low density lipoprotein (LDL)-cholesterol: 120-180mg/dL

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

62

Participant exclusion criteria

1. All subjects who are capable to cause serious allergy symptoms to foods and medical drugs
2. They ingest medical drugs or herbal medicines which will affect result of test
3. They continuously ingest foods prepared with astaxanthin during past one month or even today
4. They regularly ingest health foods and beverages which profess similar effects with test foods
5. They drink alcohol more four or more days per a week in the past three months
6. They have a history of circulatory disease, nephritis and hepatitis
7. They have digestive disease or have experienced the surgery of the digestive organs (except of surgery of appendicitis)
8. They exceed more than 2.5 of the standard value of Aspartate transaminase (AST), Alanine aminotransferase (ALT ) and gamma-glutamyltranspeptidase (γ-GT)
9. They exceed more than 9.0 ml/g of the uric acid
10. They are serious anemia
11. They participate in other clinical trial with human subjects
12. They are judged by the principle investigator to participate in this clinical trial

Recruitment start date

01/06/2010

Recruitment end date

30/09/2010

Locations

Countries of recruitment

Japan

Trial participating centre

1-1 Tsutsumidori-Amamiyamachi Aoba-ku Sendai
Miyagi
981-8555
Japan

Sponsor information

Organisation

Yamaha Motor Co., Ltd (Japan)

Sponsor details

3001-10 Kuno Fukuroi
Shizuoka
437-0061
Japan

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Yamaha Motor Co., Ltd. (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23166730

Publication citations

  1. Results

    Kiko T, Nakagawa K, Satoh A, Tsuduki T, Furukawa K, Arai H, Miyazawa T, Amyloid β levels in human red blood cells., PLoS ONE, 2012, 7, 11, e49620, doi: 10.1371/journal.pone.0049620.

Additional files

Editorial Notes