A Study to Evaluate the Effect of Astaxanthin in Healthy Participants

NCT05376501 | Completed

• 1 other identifier: L01-21-01-T0022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Inflammation; Antioxidant Effect; C-Reactive Protein; Skin; Oxidative Stress; Cholesterol; Aging

Outcome Measures

Primary Outcomes (1)

• 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

  4 and 12 weeks

Secondary Outcomes (12)

• To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo

  4 and 12 weeks

• To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo

  4 and 12 weeks

• To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo

  4 and 12 weeks

• To assess the effect of the Astaxanthin on lipid levels within the group and compared to placebo

  4 and 12 weeks

• To assess the effect of the Astaxanthin on blood flow within the group and compared to placebo

  4 and 12 weeks

Study Arms (2)

Astaxanthin

EXPERIMENTAL

Active Ingredient: Astaxanthin Inactive ingredients: Modified food starch, sucrose, water, sodium ascorbate, DL- alpha tocopherols

Dietary Supplement: Astaxanthin

Placebo

PLACEBO COMPARATOR

Modified food starch, sucrose, hylocereus polyrhizus (pitaya) concentration

Other: Placebo

Interventions

Astaxanthin DIETARY_SUPPLEMENT

8 mg Astaxanthin per capsule, taken once a day with meal

Astaxanthin

Placebo OTHER

Modified food starch

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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)

Sponsors & Collaborators

• LycoRed Ltd.: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

SGS Stephens, Inc

Richardson, Texas, 75081-1906, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shoná Burkes-Henderson, PhD

  SGS Stephens, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization at 1:1 ratio for active or placebo

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 17, 2022
• Study Start: June 8, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 15, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)