Bioavailability of Astaxanthin Formulations
1 other identifier
interventional
10
1 country
1
Brief Summary
Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 healthy-volunteers
Started Mar 2018
Typical duration for early_phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedStudy Start
First participant enrolled
March 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedMay 21, 2019
July 1, 2018
1.1 years
February 18, 2018
May 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
plasma level
astaxanthin in plasma
0-48 hr
Study Arms (4)
Astaxanthin formulation #1
ACTIVE COMPARATORcapsules
Astaxanthin formulation #2
ACTIVE COMPARATORtablets
Astaxanthin formulation #3
ACTIVE COMPARATORpowder
Astaxanthin formulations
EXPERIMENTALfast condition
Interventions
an oral dose form
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. Are unwilling to follow the procedures of the trial, such as making visits or having their blood drawn.
- \. 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).
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bert W. Strassburger Lipid Center, Sheba Medical Center,
Tel Litwinsky, 52621, Israel
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Bitzur, MD
Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2018
First Posted
February 23, 2018
Study Start
March 25, 2018
Primary Completion
May 2, 2019
Study Completion
May 30, 2019
Last Updated
May 21, 2019
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share