Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03945526
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Stroke; Malondialdehyde; Oxidative Stress	Drug: Astaxanthine; Drug: Placebo Oral Tablet	Phase 1

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

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Astaxanthin and PlaceboAstaxanthin and Placebo
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 23, 2010
• Actual Primary Completion Date: Jun 9, 2010
• Actual Study Completion Date: Jun 9, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Astaxanthin Astaxanthin supplementation will be given at 2 x 8mg for 7 days.	Drug: Astaxanthine; Other Names: Astaxanthine 8mg
Placebo Comparator: Control A placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation	Drug: Placebo Oral Tablet; Other Names: Astaxanthine placebo

Outcome Measures

Primary Outcome Measures

1. Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry [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).

2. National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition University of Indonesia	Jakarta		Indonesia	10340

Sponsors and Collaborators

• Indonesia University

Investigators

• Study Chair: Salim Harris, SpS, IDI
• Study Chair: Sri Sukmaniah, SpGK, IDI

Study Documents (Full-Text)

None provided.

More Information

Publications

• Barber PA, Demchuk AM, Hirt L, Buchan AM. Biochemistry of ischemic stroke. Adv Neurol. 2003;92:151-64. Review.
• 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.
• Gariballa SE, Sinclair AJ. Assessment and treatment of nutritional status in stroke patients. Postgrad Med J. 1998 Jul;74(873):395-9. Review.
• 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.
• Palozza P, Krinsky NI. Astaxanthin and canthaxanthin are potent antioxidants in a membrane model. Arch Biochem Biophys. 1992 Sep;297(2):291-5.
• 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.

• Responsible Party: Gabriella Nurahmani Putri, Assistant Clinical Nutrition Professor, Indonesia University
• ClinicalTrials.gov Identifier: NCT03945526
• Other Study ID Numbers: Neuronutrition
• First Posted: May 10, 2019
• Last Update Posted: May 13, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gabriella Nurahmani Putri, Assistant Clinical Nutrition Professor, Indonesia University: Astaxanthin; Antioxidant; Plasma Malondialdehyde; NIHSS score; Ischemic Stroke
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of May 13, 2019