Bioavailability of Astaxanthin Formulations

Algatechnologies

Status and phase: Unknown; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Astaxanthin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03443882

01 2018 ver1

Details and patient eligibility

About

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

Full description

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

Enrollment: 10 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

Astaxanthin formulation #1

Active Comparator group

Description:

capsules

Treatment:

Dietary Supplement: Astaxanthin

Astaxanthin formulation #2

Active Comparator group

Description:

tablets

Treatment:

Dietary Supplement: Astaxanthin

Astaxanthin formulation #3

Active Comparator group

Description:

powder

Treatment:

Dietary Supplement: Astaxanthin

Astaxanthin formulations

Experimental group

Description:

fast condition

Treatment:

Dietary Supplement: Astaxanthin