Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astaxanthin | Experimental | Active Ingredient: Astaxanthin Inactive ingredients: Modified food starch, sucrose, water, sodium ascorbate, DL- alpha tocopherols |
|
| Placebo | Placebo Comparator | Modified food starch, sucrose, hylocereus polyrhizus (pitaya) concentration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astaxanthin | Dietary Supplement | 8 mg Astaxanthin per capsule, taken once a day with meal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo | Change from baseline in c-reactive protein | 4 and 12 weeks |
| To assess the effect of the Astaxanthin on inflammation within the group and compared to placebo |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shoná Burkes-Henderson, PhD | SGS Stephens, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stephens, Inc | Richardson | Texas | 75081-1906 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C005948 | astaxanthine |
Not provided
Not provided
Not provided
Randomization at 1:1 ratio for active or placebo
Not provided
Not provided
Double blind
| Placebo |
| Other |
Modified food starch |
|
Change from baseline in tumour necrosis factor alpha |
| 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 | 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 | 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 | 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 | 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 | 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 | 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" | 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" | 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) | 12 weeks |
| To assess the safety and tolerability of the Astaxanthin in healthy participants | Collection of adverse events | Over 12 weeks |