HealthyNCT05376501
A Study to Evaluate the Effect of Astaxanthin in Healthy Participants
A study testing Astaxanthin in people with Healthy, run by LycoRed Ltd. at 1 site in United States.
Trial summary
Astaxanthin is recognized as a bioactive compound with potential benefits for human health. This study aims to evaluate a specific nutritional supplement impact on markers of oxidative stress, inflammation, lipid levels, blood flow, visual skin markers, measures of longevity, mood and skin condition. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Astaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 15 Oct 2022
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female adult participants who are 18 to 50 years of age (inclusive)
- Have a body mass index between 18.0 to 34.9 kg/m2 (inclusive)
- In good general health (no active or uncontrolled diseases or conditions)
- Participants must have negative urine pregnancy test result at baseline and agree to use acceptable birth control methods during the study
- Willing to refrain from changing their diet or lifestyle significantly for the duration of the study.
- Agree to refrain from treatments in the defined timeframe, as outlined in the protocol
- Willing and able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, carry out all study related procedures, communicate effectively with the study staff, and agree to allow all study related evaluations
Who cannot join
- Females who are lactating, pregnant or planning to become pregnant during the study duration
- Have a known allergy or hypersensitivity to astaxanthin or related carotenoids, including canthaxanthin, or have hypersensitivity to an astaxanthin source, such as Haematococcus pluvialis and known sensitivity, intolerability, or allergy to any of the study products or their excipients
- Received a vaccine for COVID-19 in the 2 weeks prior to screening, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (i.e., individuals with a history of probable or confirmed SARSCoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis)
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study
- Participants with positive medical history of heart disease/cardiovascular disease, kidney disease, hepatic impairment or disease, or any other medical condition or diagnosis that the investigator would deem exclusionary
- Participant with a positive medical history of unstable thyroid disease, immune disorder (i.e., HIV/AIDS), osteoporosis, a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit)
Show all 19Show fewer
- Participants with uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, or neurological disease are excluded. Participants beginning a new medication or dose changed within the previous 3 months will also be excluded
- Participants with diagnosed hypertension and/or diabetes
- Current smoker of cigarette or tobacco, or quit smoking less than 6 months ago, or consume any other inhalable substance, legal or otherwise
- History of hospitalization or in-patient or out-patient treatment for alcohol or drug dependence or addiction within the 12 months prior to screening. Also, current problem of drug or alcohol abuse which, in the opinion of the investigator, might interfere with participation
- History of hospitalization or in-patient treatment for depression or any related condition within the past five years. However, use of anti-anxiety/depressants is accepted as long as the dose has been consistent for a minimum of 3 months
- Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins")
- Current diagnosis of adult acne or currently on treatment for adult acne
- Participants using tanning salons or tanning products for face in the last 3 months from screening or planning to use them during the study
- Participants who plan to undergo invasive facial procedures (injections, chemical peeling, etc.) during the study or have undergone these procedures within 1 month prior to baseline
- Participants with auto-immune skin diseases (e.g., scleroderma, psoriasis, lupus, epidermolysis bullosa, bullous pemphigoid, temporal arteritis)
- Participant with any current or recent use of medications, treatments, or supplements prohibited/restricted in the protocol
- Receipt or use of test product(s) in another research study within 30 days prior to baseline visit
- Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant or the quality of the study data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Supplemental Astaxanthin in Healthy Female Adult Participants
Astaxanthin is recognized as a bioactive compound with potential benefits for human health. This study aims to evaluate a specific nutritional supplement impact on markers of oxidative stress, inflammation, lipid levels, blood flow, visual skin markers, measures of longevity, mood and skin condition.
Read the detailed description
A healthy diet is characterized by a high intake of various bioactive compounds usually found in natural, organic, and fresh foodstuffs. Among these bioactive compounds, astaxanthin, a red carotenoid pigment especially found in seafood, has been recognized in the scientific literature as a potential nutraceutical due to its antioxidant, anti-inflammatory, and neurotrophic properties. Previous studies have demonstrated reduced markers of oxidative stress and inflammation and improved blood rheology. Additionally, astaxanthin help maintain healthy skin.
This randomized, double-blind, placebo-controlled study will evaluate the impact of Astaxanthin supplemented for 12 weeks, on oxidative stress, inflammation, lipid levels, blood flow, skin hydration, visual skin markers, measures of longevity, mood states and facial skin satisfaction in healthy female adult participants.
- Conditions
- Healthy
- Being tested
- Astaxanthin, Placebo
- Keywords
- Inflammation, Antioxidant Effect, C-Reactive Protein, Skin, Oxidative Stress, Cholesterol, Aging
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthinDietary supplement
8 mg Astaxanthin per capsule, taken once a day with meal
PlaceboOther
Modified food starch
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin | Experimental | Active Ingredient:
Astaxanthin
Inactive ingredients:
Modified food starch, sucrose, water, sodium ascorbate, DL- alpha tocopherols Receives: Dietary Supplement: Astaxanthin |
| Placebo | Placebo comparator | Modified food starch, sucrose, hylocereus polyrhizus (pitaya) concentration Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of Astaxanthin on oxidative stress within the group and compared to placebo
Change from baseline in plasma/serum total antioxidant capacity
Measured: 4 and 12 weeks
Secondary outcomes (12)
To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo
Change from baseline in c-reactive protein
Measured: 4 and 12 weeks
To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo
Change from baseline in tumour necrosis factor alpha
Measured: 4 and 12 weeks
To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo
Change from baseline in Interleukin-6 and Interleukin-10
Measured: 4 and 12 weeks
To assess the effect of the Astaxanthin on lipid levels within the group and compared to placebo
Change from baseline in total cholesterol, high density lipoprotein, low density lipoprotein, and triglycerides
Measured: 4 and 12 weeks
To assess the effect of the Astaxanthin on blood flow within the group and compared to placebo
Change from baseline in blood flow rate and velocity of the brachial artery (volar forearm), as assessed by laser doppler
Measured: 4 and 12 weeks
To assess the effect of the Astaxanthin on facial skin hydration within the group and compared to placebo
Change from baseline in Trans epidermal water loss measurement on the face
Measured: 4 and 12 weeks
To assess the effect of the Astaxanthin on visual skin markers (wrinkles, pores, visible spots, tonality (complexion - even skin tone), pigmentation, roughness (texture), UV porphyrins) after 12 weeks within the group and compared to placebo
Change from baseline in Vaestro skin image analysis values from VISIA images
Measured: 12 weeks
To assess the effect of the Astaxanthin on measures of longevity within the group and compared to placebo
Change from baseline in telomere length
Measured: 12 weeks
To assess the effect of the Astaxanthin on participant reported mood states within the group and compared to placebo
Change from baseline in mood states. Mood states will be measured by Profile of Mood States (POMS) questionnaire that measures feelings description on a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely"
Measured: 4 and 12 weeks
To assess the effect of the Astaxanthin on participant reported facial skin satisfaction within the group and compared to placebo
Self-perceived facial skin satisfaction will be assessed by a self reported short skin questionnaire completed by participants. The questionnaire measures responses on a 5-point Likert scale ranging from "strongly agree" to "strongly disagree"
Measured: 4 and 12 weeks
To assess the safety and tolerability of the Astaxanthin in healthy participants
Measurement of Vitals (systolic blood pressure and diastolic blood pressure)
Measured: 12 weeks
To assess the safety and tolerability of the Astaxanthin in healthy participants
Collection of adverse events
Measured: Over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start8 Jun 2022
- Primary completion1 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization at 1:1 ratio for active or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- LycoRed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Shoná Burkes-Henderson, PhD, Principal investigator, SGS Stephens, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376501
- Sponsor's protocol ID
- L01-21-01-T0022
- Status last verified
- Nov 2022
- First submitted
- 10 May 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Supplemental Astaxanthin in Healthy Female Adult Participants
- ClinicalTrials.gov ID
- NCT05376501
- Acronym / sponsor ID
- L01-21-01-T0022
- Conditions
- Healthy
- Keywords
- Inflammation, Antioxidant Effect, C-Reactive Protein, Skin, Oxidative Stress, Cholesterol, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LycoRed Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Astaxanthin is recognized as a bioactive compound with potential benefits for human health. This study aims to evaluate a specific nutritional supplement impact on markers of oxidative stress, inflammation, lipid levels, blood flow, visual skin markers, measures of longevity, mood and skin condition.
Detailed description
A healthy diet is characterized by a high intake of various bioactive compounds usually found in natural, organic, and fresh foodstuffs. Among these bioactive compounds, astaxanthin, a red carotenoid pigment especially found in seafood, has been recognized in the scientific literature as a potential nutraceutical due to its antioxidant, anti-inflammatory, and neurotrophic properties. Previous studies have demonstrated reduced markers of oxidative stress and inflammation and improved blood rheology. Additionally, astaxanthin help maintain healthy skin.
This randomized, double-blind, placebo-controlled study will evaluate the impact of Astaxanthin supplemented for 12 weeks, on oxidative stress, inflammation, lipid levels, blood flow, skin hydration, visual skin markers, measures of longevity, mood states and facial skin satisfaction in healthy female adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization at 1:1 ratio for active or placebo
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Experimental | Dietary Supplement: AstaxanthinActive Ingredient: Astaxanthin Inactive ingredients: Modified food starch, sucrose, water, sodium ascorbate, DL- alpha tocopherols |
| Placebo | Placebo comparator | Other: PlaceboModified food starch, sucrose, hylocereus polyrhizus (pitaya) concentration |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy female adult participants who are 18 to 50 years of age (inclusive)
- Have a body mass index between 18.0 to 34.9 kg/m2 (inclusive)
- In good general health (no active or uncontrolled diseases or conditions)
- Participants must have negative urine pregnancy test result at baseline and agree to use acceptable birth control methods during the study
- Willing to refrain from changing their diet or lifestyle significantly for the duration of the study.
Key exclusion criteria (19 listed)
- Females who are lactating, pregnant or planning to become pregnant during the study duration
- Have a known allergy or hypersensitivity to astaxanthin or related carotenoids, including canthaxanthin, or have hypersensitivity to an astaxanthin source, such as Haematococcus pluvialis and known sensitivity, intolerability, or allergy to any of the study products or their excipients
- Received a vaccine for COVID-19 in the 2 weeks prior to screening, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (i.e., individuals with a history of probable or confirmed SARSCoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis)
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study
- Participants with positive medical history of heart disease/cardiovascular disease, kidney disease, hepatic impairment or disease, or any other medical condition or diagnosis that the investigator would deem exclusionary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astaxanthin8 mg Astaxanthin per capsule, taken once a day with meal | Dietary supplement | Astaxanthin |
| PlaceboModified food starch | Other | Placebo |
Primary outcome
To assess the effect of Astaxanthin on oxidative stress within the group and compared to placebo
Time frame: 4 and 12 weeks
Change from baseline in plasma/serum total antioxidant capacity
12 secondary outcomes
To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo
Time frame: 4 and 12 weeks
To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo
Time frame: 4 and 12 weeks
To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo
Time frame: 4 and 12 weeks
To assess the effect of the Astaxanthin on lipid levels within the group and compared to placebo
Time frame: 4 and 12 weeks
To assess the effect of the Astaxanthin on blood flow within the group and compared to placebo
Time frame: 4 and 12 weeks
To assess the effect of the Astaxanthin on facial skin hydration within the group and compared to placebo
Time frame: 4 and 12 weeks
To assess the effect of the Astaxanthin on visual skin markers (wrinkles, pores, visible spots, tonality (complexion - even skin tone), pigmentation, roughness (texture), UV porphyrins) after 12 weeks within the group and compared to placebo
Time frame: 12 weeks
To assess the effect of the Astaxanthin on measures of longevity within the group and compared to placebo
Time frame: 12 weeks
To assess the effect of the Astaxanthin on participant reported mood states within the group and compared to placebo
Time frame: 4 and 12 weeks
To assess the effect of the Astaxanthin on participant reported facial skin satisfaction within the group and compared to placebo
Time frame: 4 and 12 weeks
To assess the safety and tolerability of the Astaxanthin in healthy participants
Time frame: 12 weeks
To assess the safety and tolerability of the Astaxanthin in healthy participants
Time frame: Over 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shoná Burkes-Henderson, PhD principal investigator
SGS Stephens, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin in people with Healthy, run by LycoRed Ltd. 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?
The sponsor lists 7 inclusion and 19 exclusion criteria. 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 1 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
To assess the effect of Astaxanthin on oxidative stress within the group and compared to placebo (time frame: 4 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2022.