Cerebral StrokePhase 1NCT03945526
Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients
A Phase 1 study testing Astaxanthine in people with Cerebral Stroke and Malondialdehyde, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This is an interventional randomized, controlled trial in analyzing the effects of astaxanthin supplementation on plasma malondialdehyde levels and NIHSS of acute ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cerebral Stroke, Malondialdehyde, Oxidative Stress
- What is being tested?
- Astaxanthine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Mar 2010to 9 Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-65 years old
- Has acute ischemic stroke with an onset of less than 48 hours before hospital admission
- NIHSS score of less than or equal to 15
- Can consume food orally or enterally
- Has given their consent to be a participant in the study
Who cannot join
- Renal failure
- Liver failure
- Is taking supplements other than his or her main stroke medications
- Has taken antioxidant supplements in the last 3 months before stroke onset
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Nutrition University of Indonesia
Jakarta, 10340
About this study
Official title: Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and National Institute of Health Stroke Scale Score of Acute Ischemic Stroke Patients: A Randomized Trial
This is an interventional randomized, controlled trial in analyzing the effects of astaxanthin supplementation on plasma malondialdehyde levels and NIHSS of acute ischemic stroke patients. According to published studies, it was hypothesized that acute ischemic stroke patients who were given astaxanthin would have lower plasma malondialdehyde levels and lower NIHSS score compared to the control group.
Read the detailed description
There were a total of 24 subjects, with 12 subjects in the intervention group and 12 subjects in the control group.The participants were divided into an interventional group and a control group. The interventional group was given astaxanthin supplementation 2 x 8mg per day for 7 days, while the control group was given placebo.
- Conditions
- Cerebral Stroke, Malondialdehyde, Oxidative Stress
- Being tested
- Astaxanthine, Placebo Oral Tablet
- Keywords
- Astaxanthin, Antioxidant, Plasma Malondialdehyde, NIHSS score, Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthineDrug
Also called Astaxanthine 8mg
Placebo Oral TabletDrug
Also called Astaxanthine placebo
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin | Active comparator | Astaxanthin supplementation will be given at 2 x 8mg for 7 days. Receives: Drug: Astaxanthine |
| Control | Placebo comparator | A placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry
This method used Thiobarbituric acid reaction (TBAR) with substances such as malondialdehyde. The scale was 0.367 nmol/ml-0.707 nmol/ml. The value above 0.707nmol/ml would be the worse outcome, and value less than 0.367nmol/ml would be the best outcome. Bivariate analysis was used to analyze the results (T-test or the Mann-Whitney Test).
Measured: 7 days
National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients
Score scale was 4-15, where less than 4 indicates mild neurologic deficit, 4-15 moderate neurologic deficit, and more than 15 severe neurologic deficit. They will be assessed before and after the trial to compare how each participant improved after given the intervention.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start23 Mar 2010
- Primary completion9 Jun 2010
- Study completion9 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Astaxanthin and Placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriella Nurahmani Putri, Universitas Indonesia
- Investigators
- Salim Harris, SpS, Study chair, IDISri Sukmaniah, SpGK, Study chair, IDI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945526
- Sponsor's protocol ID
- Neuronutrition
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barber PA, Demchuk AM, Hirt L, Buchan AM. Biochemistry of ischemic stroke. Adv Neurol. 2003;92:151-64. No abstract available.
PubMed 12760178Shen H, Kuo CC, Chou J, Delvolve A, Jackson SN, Post J, Woods AS, Hoffer BJ, Wang Y, Harvey BK. Astaxanthin reduces ischemic brain injury in adult rats. FASEB J. 2009 Jun;23(6):1958-68. doi: 10.1096/fj.08-123281. Epub 2009 Feb 13.
PubMed 19218497Palozza P, Krinsky NI. Astaxanthin and canthaxanthin are potent antioxidants in a membrane model. Arch Biochem Biophys. 1992 Sep;297(2):291-5. doi: 10.1016/0003-9861(92)90675-m.
PubMed 1497349Hussein G, Nakamura M, Zhao Q, Iguchi T, Goto H, Sankawa U, Watanabe H. Antihypertensive and neuroprotective effects of astaxanthin in experimental animals. Biol Pharm Bull. 2005 Jan;28(1):47-52. doi: 10.1248/bpb.28.47.
PubMed 15635162Gariballa SE, Sinclair AJ. Assessment and treatment of nutritional status in stroke patients. Postgrad Med J. 1998 Jul;74(873):395-9. doi: 10.1136/pgmj.74.873.395.
PubMed 9799909Demirkaya S, Topcuoglu MA, Aydin A, Ulas UH, Isimer AI, Vural O. Malondialdehyde, glutathione peroxidase and superoxide dismutase in peripheral blood erythrocytes of patients with acute cerebral ischemia. Eur J Neurol. 2001 Jan;8(1):43-51. doi: 10.1046/j.1468-1331.2001.00166.x.
PubMed 11509080
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and National Institute of Health Stroke Scale Score of Acute Ischemic Stroke Patients: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03945526
- Acronym / sponsor ID
- Neuronutrition
- Conditions
- Cerebral Stroke, Malondialdehyde, Oxidative Stress
- Keywords
- Astaxanthin, Antioxidant, Plasma Malondialdehyde, NIHSS score, Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 23 Mar 2010 (actual)
- Primary completion
- 9 Jun 2010 (actual)
- Study completion
- 9 Jun 2010 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional randomized, controlled trial in analyzing the effects of astaxanthin supplementation on plasma malondialdehyde levels and NIHSS of acute ischemic stroke patients. According to published studies, it was hypothesized that acute ischemic stroke patients who were given astaxanthin would have lower plasma malondialdehyde levels and lower NIHSS score compared to the control group.
Detailed description
There were a total of 24 subjects, with 12 subjects in the intervention group and 12 subjects in the control group.The participants were divided into an interventional group and a control group. The interventional group was given astaxanthin supplementation 2 x 8mg per day for 7 days, while the control group was given placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Astaxanthin and Placebo
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Active comparator | Drug: AstaxanthineAstaxanthin supplementation will be given at 2 x 8mg for 7 days. |
| Control | Placebo comparator | Drug: Placebo Oral TabletA placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 40-65 years old
- Has acute ischemic stroke with an onset of less than 48 hours before hospital admission
- NIHSS score of less than or equal to 15
- Can consume food orally or enterally
- Has given their consent to be a participant in the study
Key exclusion criteria (4 listed)
- Renal failure
- Liver failure
- Is taking supplements other than his or her main stroke medications
- Has taken antioxidant supplements in the last 3 months before stroke onset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AstaxanthineAlso: Astaxanthine 8mg | Drug | Astaxanthin |
| Placebo Oral TabletAlso: Astaxanthine placebo | Drug | Control |
Primary outcome
Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry
Time frame: 7 days
This method used Thiobarbituric acid reaction (TBAR) with substances such as malondialdehyde. The scale was 0.367 nmol/ml-0.707 nmol/ml. The value above 0.707nmol/ml would be the worse outcome, and value less than 0.367nmol/ml would be the best outcome. Bivariate analysis was used to analyze the results (T-test or the Mann-Whitney Test).
National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients
Time frame: 7 days
Score scale was 4-15, where less than 4 indicates mild neurologic deficit, 4-15 moderate neurologic deficit, and more than 15 severe neurologic deficit. They will be assessed before and after the trial to compare how each participant improved after given the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Background: PubMed 12760178Barber PA, Demchuk AM, Hirt L, Buchan AM. Biochemistry of ischemic stroke. Adv Neurol. 2003;92:151-64. No abstract available.
- Background: PubMed 19218497Shen H, Kuo CC, Chou J, Delvolve A, Jackson SN, Post J, Woods AS, Hoffer BJ, Wang Y, Harvey BK. Astaxanthin reduces ischemic brain injury in adult rats. FASEB J. 2009 Jun;23(6):1958-68. doi: 10.1096/fj.08-123281. Epub 2009 Feb 13.
- Background: PubMed 1497349Palozza P, Krinsky NI. Astaxanthin and canthaxanthin are potent antioxidants in a membrane model. Arch Biochem Biophys. 1992 Sep;297(2):291-5. doi: 10.1016/0003-9861(92)90675-m.
- Background: PubMed 15635162Hussein G, Nakamura M, Zhao Q, Iguchi T, Goto H, Sankawa U, Watanabe H. Antihypertensive and neuroprotective effects of astaxanthin in experimental animals. Biol Pharm Bull. 2005 Jan;28(1):47-52. doi: 10.1248/bpb.28.47.
- Background: PubMed 9799909Gariballa SE, Sinclair AJ. Assessment and treatment of nutritional status in stroke patients. Postgrad Med J. 1998 Jul;74(873):395-9. doi: 10.1136/pgmj.74.873.395.
- Background: PubMed 11509080Demirkaya S, Topcuoglu MA, Aydin A, Ulas UH, Isimer AI, Vural O. Malondialdehyde, glutathione peroxidase and superoxide dismutase in peripheral blood erythrocytes of patients with acute cerebral ischemia. Eur J Neurol. 2001 Jan;8(1):43-51. doi: 10.1046/j.1468-1331.2001.00166.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salim Harris, SpS study chair
IDI
Sri Sukmaniah, SpGK study chair
IDI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Astaxanthine in people with Cerebral Stroke and Malondialdehyde, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945526, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.