Bioavailability of Astaxanthin Formulations

Healthy Volunteers Clinical Trial

Official title:

Bioavailability of Astaxanthin Formulations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03443882
• Other study ID #: 01 2018 ver1
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: March 25, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: July 2018
• Source: Algatechnologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 30, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Astaxanthin
an oral dose form

Locations

Country	Name	City	State
Israel	Bert W. Strassburger Lipid Center, Sheba Medical Center,	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Algatechnologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma level	astaxanthin in plasma	0-48 hr