Bioavailability of Astaxanthin Formulations

Early Phase 1

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Astaxanthin

• Registration Number: NCT03443882
• Lead Sponsor: Algatechnologies Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-02-18
• Study First Submitted QC: 2018-02-18
• Study First Posted: 2018-02-23
• Study Start: 2018-03-25
• Status Verified: 2018-07
• Primary Completion: 2019-05-02
• Last Update Submitted: 2019-05-19
• Last Update Posted: 2019-05-21
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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).

  3. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Astaxanthin formulations	Astaxanthin	fast condition
Astaxanthin formulation #1	Astaxanthin	capsules
Astaxanthin formulation #3	Astaxanthin	powder
Astaxanthin formulation #2	Astaxanthin	tablets

Primary Outcome Measures

Name	Time	Method
plasma level	0-48 hr	astaxanthin in plasma

Trial Locations

Locations (1)

Bert W. Strassburger Lipid Center, Sheba Medical Center,; 🇮🇱 Tel Hashomer, Israel