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Bioavailability of Astaxanthin FormulationsNCT02397811

Astaxanthin Formulation Bioavailability

A study testing Enteric Coated Softgels, Liposomal astaxanthin and Standard Softgel in people with Bioavailability of Astaxanthin Formulations, run by Cyanotech Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Human crossover pharmacokinetic study involving 12 subjects to determine the relative bioavailability of astaxanthin in six commercially available oral formulations. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
What is being tested?
Enteric Coated Softgels, Liposomal astaxanthin and Standard Softgel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Jun 2015to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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 65 years of age, inclusive, at the baseline visit.

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Exclusion Criteria:Subjects who meet any of the following exclusion criteria are not eligible for participation in this clinical trial:

  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 pounds 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. 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 (12 ounces) equals one glass of wine (4 ounces) equals one ounce of hard liquor).
  6. Have a Body Mass Index (BMI) of less than 15 or greater than 55 m/kg2;
  7. Have participated in a clinical trial in the past 4 weeks;
  8. Have any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject;
  9. Severe co-morbid disease is defined as any condition that would cause severe limitations or inability to carry out usual activities of daily living.
  10. The exclusion criteria identified above are based upon general safety concerns identified by the study supervisor with input from medical director, or confounders identified by the biostatistician. -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USF Health: College of Medicine

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Bioavailability Testing of Astaxanthin Formulations

Human crossover pharmacokinetic study involving 12 subjects to determine the relative bioavailability of astaxanthin in six commercially available oral formulations.

Read the detailed description

Astaxanthin is commercially available through several vendors. As a highly-lipophilic compound, its oral bioavailability is likely limited by its solubility in the gut. Pre-formulation strategies for addressing limited solubility include pre-dissolving the astaxanthin in fatty solvents and encapsulating in gelatin capsules. This study will evaluate the oral bioavailability of six different formulations of astaxanthin (12mg) in a double blind crossover study involving 12 subjects.

All subjects will be asked to abstain from consuming any salmon 48hrs before and consuming any food or alcoholic beverages 10 hours before reporting to the blood draw center at 8 AM. They will be fed a standardized breakfast by choosing one of two Jimmy Dean brand breakfast sandwiches (EGG, RED PEPPERS, ONIONS AND PEPPER JACK CHEESE CROISSANT or BACON, EGG \& CHEESE BISCUIT. Immediately following the standardized meal, they will take one of six different formulations each containing 12 mg of astaxanthin. Bottled water (Zephyrhills® Brand 100% Natural Spring Water) will be available to each subject ad lib. Blood will be collected immediately before consuming the standardized meal and formulation (0 hr) and then again at 4, 8, 10, and 24 hours post dose by a licensed phlebotomist. In between blood draws, the subjects will be allowed to leave the clinic and allowed to resume their normal diet and lifestyle. However, they will be asked to abstain from consuming any alcoholic beverages or salmon until after completion of the last blood draw at 24hrs. As a measure of quality control, each subject will receive a breathalyzer test for alcohol prior to the 0 and 24 hr blood draws. For each time point, blood will be collected in one 10ml Vacutainer Tube (BD 16x100 containing K2 EDTA) labeled using the randomization scheme to blind the samples. Because 3 of the formulations are powders and the remaining 3 formulations are capsules, which differ slightly size and appearance, neither the subjects nor investigators will be blind to the formulation being tested on any given day. However, each subject will receive separate random assignment to each of the 6 formulations tested over the course of the study and all blood samples will be blinded to the quantitative analysis of astaxanthin plasma levels. This process will be repeated six times for the entire subject population (with-in subject design) with two-week washout periods between each pharmacokinetic (pK) run. The blinded blood samples will be kept refrigerated and will be transported to the Center for Excellence and Brain Repair (CEABR) lab within 24 hours, where it will be processed and subjected to the High pressure liquid chromatograph (HPLC) analysis to quantify the astaxanthin.

Being tested
Enteric Coated Softgels, Liposomal astaxanthin, Standard Softgel, Astaxanthin Water Soluble Emulsion, Astaxanthin Water Dispersible Powder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enteric Coated SoftgelsDietary supplement

    Also called BioAstin

    Enteric coated softgel capsule containing 4 mg astaxanthin, 3 softgels per dose

  • Liposomal astaxanthinDietary supplement

    Also called BioAstin

    Liposomal astaxanthin containing 4.5 mg astaxanthin per gram. 3.66 grams per dose

  • Standard SoftgelDietary supplement

    Also called BoAstin

    Standard softgel containing 4 mg astaxanthin per softgel. 3 softgels per dose

  • Astaxanthin Water Soluble EmulsionDietary supplement

    Also called BioAstin

    Astaxanthin water soluble emulsion containing 1% astaxanthin. 1.2 grams per dose

  • Astaxanthin Water Dispersible PowderDietary supplement

    Also called BioAstin

    Astaxanthin water dispersible powder containing 3% astaxanthin. 0.4 grams per dose

  • Standard Softgel with Astaxanthin GelDietary supplement

    Also called BioAstin

    Standard softgel with astaxanthin gel containing 4 mg astaxanthin. 3 soft gels per dose

Study groups in NCT02397811
Study groupRoleWhat they receive
Enteric Coated SoftgelsExperimentalEnteric coated softgel capsule containing 4 mg astaxanthin, 3 softgels per dose
Receives: Dietary Supplement: Enteric Coated Softgels
Liposomal AstaxanthinExperimentalLiposomal astaxanthin containing 4.5 mg astaxanthin per gram. 2.66 grams per dose
Receives: Dietary Supplement: Liposomal astaxanthin
Standard SoftgelExperimentalStandard softgel containing 4 mg per softgel. 3 softgels per dose
Receives: Dietary Supplement: Standard Softgel
Astaxanthin Water Soluble EmulsionExperimentalAstaxanthin water soluble emulsion containing 1% astaxanthin. 1.2 grams per dose
Receives: Dietary Supplement: Astaxanthin Water Soluble Emulsion
Astaxanthin Water Dispersible PowderExperimentalAstaxanthin water dispersible powder containing 3% astaxanthin. 0.4 grams per dose
Receives: Dietary Supplement: Astaxanthin Water Dispersible Powder
Standard Softgel with Astaxanthin GelExperimentalStatndard softgel with astaxanthin gel containing 4 mg astaxanthin. 3 softgels per dose
Receives: Dietary Supplement: Standard Softgel with Astaxanthin Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plasma Concentration Cmax) of astaxanthin

    Measured: 24 hurs

  2. Area under the plasma concentration versus time curve (AUC) of astaxanthin

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02397811
Sponsor's protocol ID
Pro00019850
Status last verified
Jan 2016
First submitted
20 Mar 2015
Last updated
9 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Baralic I, Djordjevic B, Dikic N, Kotur-Stevuljevic J, Spasic S, Jelic-Ivanovic Z, Radivojevic N, Andjelkovic M, Pejic S. Effect of astaxanthin supplementation on paraoxonase 1 activities and oxidative stress status in young soccer players. Phytother Res. 2013 Oct;27(10):1536-42. doi: 10.1002/ptr.4898. Epub 2012 Nov 28.

    PubMed 23192897

  • Barros MP, Marin DP, Bolin AP, de Cassia Santos Macedo R, Campoio TR, Fineto C Jr, Guerra BA, Polotow TG, Vardaris C, Mattei R, Otton R. Combined astaxanthin and fish oil supplementation improves glutathione-based redox balance in rat plasma and neutrophils. Chem Biol Interact. 2012 Apr 15;197(1):58-67. doi: 10.1016/j.cbi.2012.03.005. Epub 2012 Mar 21.

    PubMed 22465178

  • Bolin AP, Macedo RC, Marin DP, Barros MP, Otton R. Astaxanthin prevents in vitro auto-oxidative injury in human lymphocytes. Cell Biol Toxicol. 2010 Oct;26(5):457-67. doi: 10.1007/s10565-010-9156-4. Epub 2010 Mar 14.

    PubMed 20229275

  • Smith AJ, Kavuru P, Wojtas L, Zaworotko MJ, Shytle RD. Cocrystals of quercetin with improved solubility and oral bioavailability. Mol Pharm. 2011 Oct 3;8(5):1867-76. doi: 10.1021/mp200209j. Epub 2011 Aug 25.

    PubMed 21846121

  • Smith AJ, Kavuru P, Arora KK, Kesani S, Tan J, Zaworotko MJ, Shytle RD. Crystal engineering of green tea epigallocatechin-3-gallate (EGCg) cocrystals and pharmacokinetic modulation in rats. Mol Pharm. 2013 Aug 5;10(8):2948-61. doi: 10.1021/mp4000794. Epub 2013 Jun 26.

    PubMed 23730870

Questions about this trial

What is this clinical trial studying?

A study testing Enteric Coated Softgels, Liposomal astaxanthin and Standard Softgel in people with Bioavailability of Astaxanthin Formulations, run by Cyanotech Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration Cmax) of astaxanthin (time frame: 24 hurs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02397811, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.

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