NCT05376501已完成不适用
A Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Supplemental Astaxanthin in Healthy Female Adult Participants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LycoRed Ltd.
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To assess the effect of Astaxanthin on oxidative stress within the group and compared to placebo
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
- •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
结局指标
主要结局
To assess the effect of Astaxanthin on oxidative stress within the group and compared to placebo
时间窗: 4 and 12 weeks
Change from baseline in plasma/serum total antioxidant capacity
次要结局
- To assess the effect of the Astaxanthin on participant reported mood states within the group and compared to placebo(4 and 12 weeks)
- To assess the safety and tolerability of the Astaxanthin in healthy participants(Over 12 weeks)
- To assess the effect of the Astaxanthin on blood flow within the group and compared to placebo(4 and 12 weeks)
- To assess the effect of the Astaxanthin on facial skin hydration 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 participant reported facial skin satisfaction within the group and compared to placebo(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(12 weeks)
- To assess the effect of the Astaxanthin on measures of longevity within the group and compared to placebo(12 weeks)
- To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo(4 and 12 weeks)
研究者
研究点 (2)
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