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Bioavailability of Astaxanthin Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03443882
Recruitment Status : Active, not recruiting
First Posted : February 23, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Algatechnologies Ltd.

Brief Summary:
Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Astaxanthin Early Phase 1

Detailed Description:
Comparison of the bioavailability of 3 formulations with astaxanthin in healthy volunteers after single dose

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bioavailability of Astaxanthin Formulations
Actual Study Start Date : March 25, 2018
Actual Primary Completion Date : May 2, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Astaxanthin

Arm Intervention/treatment
Active Comparator: Astaxanthin formulation #1
capsules
Dietary Supplement: Astaxanthin
an oral dose form

Active Comparator: Astaxanthin formulation #2
tablets
Dietary Supplement: Astaxanthin
an oral dose form

Active Comparator: Astaxanthin formulation #3
powder
Dietary Supplement: Astaxanthin
an oral dose form

Experimental: Astaxanthin formulations
fast condition
Dietary Supplement: Astaxanthin
an oral dose form




Primary Outcome Measures :
  1. plasma level [ Time Frame: 0-48 hr ]
    astaxanthin in plasma



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who have signed an informed consent form and who meet all of the following entrance criteria may be enrolled in this clinical trial: Generally, healthy men and women who are 21 to 50 years of age, inclusive, at the baseline visit.

Exclusion Criteria:

  • 1. Are unwilling to follow the procedures of the trial, such as making visits or having their blood drawn.

    2. Have unintentionally lost or gained 10 or more kg of body weight in the last 3 months; 3. Have an acute illness (such as a severe cold or flu) or have been hospitalized within the past month for certain conditions; 4. Have severe co-morbid disease including cardiac, pulmonary, renal, hepatic, carotid, peripheral vascular disease, stroke, neurological, clotting disorders or active cancer; 5. Taking chronic drugs which interfere with lipids metabolism (statins or similar) 6. Consume alcohol at an elevated level (Defined as consumption of more than 10 standard alcoholic drinks per week. A standard alcoholic drink is defined as one bottle/can of beer or one glass of wine equals one portion of hard liquor).

    7. Consume carotenoids as food supplements. 8. Have a Body Mass Index (BMI) of less than 17 or greater than 35 m/kg2; 9. Have participated in a clinical trial in the past 4 weeks; 10. Have any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject; 11. Smokers 12. Pregnant woman


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443882


Locations
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Israel
Bert W. Strassburger Lipid Center, Sheba Medical Center,
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Algatechnologies Ltd.
Investigators
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Principal Investigator: Rafael Bitzur, MD Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer

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Responsible Party: Algatechnologies Ltd.
ClinicalTrials.gov Identifier: NCT03443882     History of Changes
Other Study ID Numbers: 01 2018 ver1
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No