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

NCT03945526 | Completed Phase 1

• 1 other identifier: Neuronutrition
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Stroke; Malondialdehyde; Oxidative Stress

Keywords

Astaxanthin; Antioxidant; Plasma Malondialdehyde; NIHSS score; Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  7 days

Study Arms (2)

Astaxanthin

ACTIVE COMPARATOR

Astaxanthin supplementation will be given at 2 x 8mg for 7 days.

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

Drug: Placebo Oral Tablet

Interventions

Astaxanthine DRUG

Also known as: Astaxanthine 8mg

Astaxanthin

Placebo Oral Tablet DRUG

Also known as: Astaxanthine placebo

Control

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Department of Nutrition University of Indonesia

Jakarta, 10340, Indonesia

Location

Related Publications (6)

• Barber PA, Demchuk AM, Hirt L, Buchan AM. Biochemistry of ischemic stroke. Adv Neurol. 2003;92:151-64. No abstract available.

  PMID: 12760178 BACKGROUND

• 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.

  PMID: 19218497 BACKGROUND

• 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.

  PMID: 1497349 BACKGROUND

• 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.

  PMID: 15635162 BACKGROUND

• 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.

  PMID: 9799909 BACKGROUND

• 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.

  PMID: 11509080 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Salim Harris, SpS

  IDI

  STUDY CHAIR

• Sri Sukmaniah, SpGK

  IDI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Nutrition Professor

Model Details: Astaxanthin and Placebo

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: March 23, 2010
• Primary Completion: June 9, 2010
• Study Completion: June 9, 2010
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)