Clinical trial NCT03945526: Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebral Stroke
Malondialdehyde
Oxidative Stress
Keywords: Astaxanthin
Antioxidant
Plasma Malondialdehyde
NIHSS score
Ischemic Stroke
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Astaxanthin and Placebo
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry
timeFrame: 7 days
measure: National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Department of Nutrition University of Indonesia
Study officials:
affiliation: IDI
name: Salim Harris, SpS
role: STUDY_CHAIR
affiliation: IDI
name: Sri Sukmaniah, SpGK
role: STUDY_CHAIR
References:
citation: Barber PA, Demchuk AM, Hirt L, Buchan AM. Biochemistry of ischemic stroke. Adv Neurol. 2003;92:151-64. No abstract available.
citation: Shen 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.
citation: Palozza 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.
citation: Hussein 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.
citation: Gariballa 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.
citation: Demirkaya 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.