Bioavailability of Astaxanthin Formulations

NCT ID: NCT03443882

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-25
• Study Completion Date: 2019-05-30

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Astaxanthin formulation #1

capsules

Group Type: ACTIVE_COMPARATOR

Astaxanthin

Intervention Type: DIETARY_SUPPLEMENT

an oral dose form

Astaxanthin formulation #2

tablets

Group Type: ACTIVE_COMPARATOR

Astaxanthin

Intervention Type: DIETARY_SUPPLEMENT

an oral dose form

Astaxanthin formulation #3

powder

Group Type: ACTIVE_COMPARATOR

Astaxanthin

Intervention Type: DIETARY_SUPPLEMENT

an oral dose form

Astaxanthin formulations

fast condition

Group Type: EXPERIMENTAL

Astaxanthin

Intervention Type: DIETARY_SUPPLEMENT

an oral dose form

Interventions

Astaxanthin

an oral dose form

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Algatechnologies Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Bitzur, MD

Role: PRINCIPAL_INVESTIGATOR

Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer

Locations

Bert W. Strassburger Lipid Center, Sheba Medical Center,

Tel Litwinsky, , Israel

Countries

Israel

Other Identifiers

01 2018 ver1

Identifier Type: -

Identifier Source: org_study_id