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

NCT ID: NCT03945526

Last Updated: 2019-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-23

Study Completion Date

2010-06-09

Brief Summary

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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

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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

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Cerebral Stroke Malondialdehyde Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Astaxanthin and Placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Astaxanthin

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

Group Type ACTIVE_COMPARATOR

Astaxanthine

Intervention Type DRUG

Control

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Interventions

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Astaxanthine

Intervention Type DRUG

Placebo Oral Tablet

Intervention Type DRUG

Other Intervention Names

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Astaxanthine 8mg Astaxanthine placebo

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Gabriella Nurahmani Putri

Assistant Clinical Nutrition Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salim Harris, SpS

Role: STUDY_CHAIR

IDI

Sri Sukmaniah, SpGK

Role: STUDY_CHAIR

IDI

Locations

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Department of Nutrition University of Indonesia

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

References

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

Reference Type BACKGROUND
PMID: 12760178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19218497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1497349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15635162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9799909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11509080 (View on PubMed)

Other Identifiers

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Neuronutrition

Identifier Type: -

Identifier Source: org_study_id

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