Bioavailability of Astaxanthin Formulations

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

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Astaxanthin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • Bert W. Strassburger Lipid Center, Sheba Medical Center,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma level	astaxanthin in plasma	0-48 hr

Collaborators and Investigators

• Sponsor: Algatechnologies Ltd.
• Investigators: Principal Investigator: Rafael Bitzur, MD, Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2018
• Primary Completion (Actual): May 2, 2019
• Study Completion (Anticipated): May 30, 2019

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: February 18, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 19, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 01 2018 ver1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No