Amyloid β levels in human red blood cells
| ISRCTN | ISRCTN42483402 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42483402 |
| Secondary identifying numbers | HR-2010-YH03 |
- Submission date
- 26/06/2012
- Registration date
- 01/08/2012
- Last edited
- 30/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Alzheimer's disease is the most common form of dementia. It is associated with the accumulation of amyloid β-peptide (Aβ) in the brain. Besides the brain, several changes have been observed in the blood of dementia patients, such as distortions and rapid aging of red blood cells, and an abnormal accumulation of phospholipid hydroperoxides (PLOOH), a sign of membrane oxidative injury. Aβ has been found to cause oxidative injury to red blood cells, impairing their function (i.e., oxygen delivery to the brain), which may contribute to Alzheimer's disease. However, no extensive study has been undertaken of the presence and distribution of Aβ in red blood cells. The aim of this study is to assess the distribution of Aβ in the red blood cells of young and older people.
Who can participate?
People aged 20-69 with total cholesterol level 200-260mg/dL or LDL-cholesterol level 120-180mg/dL
What does the study involve?
The red blood cells Aβ levels are compared between young and older people and also compared to plasma Aβ levels. In addition, a study was previously conducted to find out whether nutritional supplementation with the antioxidant astaxanthin affects red blood cell PLOOH. Red blood cells obtained from this study also have their Aβ levels measured in order to look to the relationship between red blood cell Aβ and antioxidants/oxidants.
What are the possible benefits and risks of participating?
All participants are likely to benefit from general advice. Those with decreasing PLOOH levels have may gain additional benefit, although the effectiveness of this process has not yet been proved. Potential risks include brief pain when drawing blood. This is likely to be similar to the normal muscle ache that people often get and is likely to go away after a couple of minutes.
Where is the study run from?
Shirogane Exe Clinic and Tohoku University (Japan)
When is the study starting and how long is it expected to run for?
June 2010 to September 2010
Who is funding the study?
Yamaha Motor Co., Ltd (Japan)
Who is the main contact?
Associate Professor Kiyotaka Nakagawa
Contact information
Scientific
1-1 Tsutsumidori-Amamiyamachi Aoba-ku Sendai
Miyagi
981-8555
Japan
Study information
| Study design | Randomized double-blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Amyloid β levels in human red blood cells: a randomized controlled trial |
| Study objectives | 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(s) | Ethical Committee of TES Holdings,17/05/2010, ref: 2010-04 |
| Health condition(s) or problem(s) studied | 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 | Supplement |
| Primary outcome measure | 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 study start date | 01/06/2010 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 62 |
| Key inclusion criteria | 1. Male and female, aged 20-69 2. Blood Test Value: Total Cholesterol: 200-260mg/dL or low density lipoprotein (LDL)-cholesterol: 120-180mg/dL |
| Key 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 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 have serious anemia 11. They participate in other clinical trial with human subjects 12. They are judged by the principal investigator to participate in this clinical trial |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- Japan
Study participating centre
981-8555
Japan
Sponsor information
Industry
3001-10 Kuno Fukuroi
Shizuoka
437-0061
Japan
"ROR" |
https://ror.org/05s7fvh27 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2012 | Yes | No |
Editorial Notes
30/06/2017: Plain English summary added.
