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

Primary Purpose

Cerebral Stroke, Malondialdehyde, Oxidative Stress

Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Astaxanthine
Placebo Oral Tablet
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Stroke focused on measuring Astaxanthin, Antioxidant, Plasma Malondialdehyde, NIHSS score, Ischemic Stroke

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Nutrition University of Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Astaxanthin

Control

Arm Description

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

A placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2019
Last Updated
May 9, 2019
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT03945526
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2010 (Actual)
Primary Completion Date
June 9, 2010 (Actual)
Study Completion Date
June 9, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Malondialdehyde, Oxidative Stress
Keywords
Astaxanthin, Antioxidant, Plasma Malondialdehyde, NIHSS score, Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Astaxanthin and Placebo
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astaxanthin
Arm Type
Active Comparator
Arm Description
Astaxanthin supplementation will be given at 2 x 8mg for 7 days.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
A placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation
Intervention Type
Drug
Intervention Name(s)
Astaxanthine
Other Intervention Name(s)
Astaxanthine 8mg
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Astaxanthine placebo
Primary Outcome Measure Information:
Title
Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry
Description
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).
Time Frame
7 days
Title
National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salim Harris, SpS
Organizational Affiliation
IDI
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sri Sukmaniah, SpGK
Organizational Affiliation
IDI
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Nutrition University of Indonesia
City
Jakarta
ZIP/Postal Code
10340
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12760178
Citation
Barber PA, Demchuk AM, Hirt L, Buchan AM. Biochemistry of ischemic stroke. Adv Neurol. 2003;92:151-64. No abstract available.
Results Reference
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PubMed Identifier
19218497
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.
Results Reference
background
PubMed Identifier
1497349
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.
Results Reference
background
PubMed Identifier
15635162
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.
Results Reference
background
PubMed Identifier
9799909
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.
Results Reference
background
PubMed Identifier
11509080
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.
Results Reference
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Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients

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