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
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
-
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.