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| Name | Class |
|---|---|
| Bio-Gen Extracts Pvt. Ltd. | UNKNOWN |
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The goal of this study is to investigate the efficacy of carotenoids administered orally on skin health, skin condition and visible signs of ageing in healthy females aged 40-55 years old.
Researchers will compare the study product against placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CaroRite | Experimental | CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotenoids | Dietary Supplement | CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the study period in Visible signs of ageing | Assessed using the A-One Smart Pro, this device provides and automatic skin analysis by scanner and multi-sensor. It uses a high-resolution camera to take photographs of the skin in normal, UV and polarized light. Wrinkles will be measured as thin and thick and rated on a scale of 1-10 in each area of the face: forehead, eyes, mouth and nose. An attached probe measures skin temperature and moisture. Visible signs of ageing measured include:
| Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the study period in Transepidermal water loss (TEWL) | Change from baseline to the end of the study period in Transepidermal water loss (TEWL). Analysed using a DermaLab Combo system with a probe for measurement. | Baseline to week 12 |
| Change from baseline to the end of the study period in Skin collagen thickness |
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Inclusion Criteria:
Exclusion Criteria:
Regularly taking carotenoid containing medication/supplements within the previous 2 months
Have a serious illness e.g. mood disorders such as clinical depression, anxiety disorder or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
Have an unstable illness e.g. diabetes and thyroid gland dysfunction
Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
Received cosmetic surgery or procedures, including Botox and other injectables, microdermabrasion and laser treatments on their face within last 3 months prior to enrolment and agree not to have these treatments during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Salman Mehkri | Bio-gen Extracts | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002338 | Carotenoids |
| ID | Term |
|---|---|
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Placebo | Other | Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks. |
|
Change from baseline to the end of the study period in Skin collagen thickness. Analysed using the DermaLab Combo system with a probe to measure. |
| Baseline to week 12 |
| Change from baseline to the end of the study period in Skin carotenoid analysis | Change from baseline to the end of the study period in Skin carotenoid analysis. This will be measured using a non-invasive device that measures skin carotenoid levels using reflection spectroscopy. | Baseline to week 12 |
| Change from baseline to the end of the study period in Safety and adverse events | Change from baseline to the end of the study period in Safety and adverse events. At each point of contact the participant will be asked about adverse events they may have experienced. | Baseline to week 12 |
| Change from baseline to the end of the study period in Participant self-assessment of product effectiveness | Change from baseline to the end of the study period in Participant self-assessment of product effectiveness. This Consists of questions related to overall satisfaction with the product and specific facial and skin properties | Baseline to week 12 |
| Change from baseline to the end of the study period in Self-administered carotenoid intake questionnaire | Change from baseline to the end of the study period in Self-administered carotenoid intake questionnaire. The questionnaire consists of 17 questions related to overall satisfaction with the product and specific facial and skin properties. | Baseline to week 12 |
| Change from baseline to the end of the study period in 24-hour diet recall | Change from baseline to the end of the study period in 24-hour diet recall | Baseline to week 12 |
| Skin carotenoid analysis (Veggie Metre) | Change from baseline to the end of the study period in Skin carotenoid analysis (Veggie Metre). Analysed using the Veggie Meter analyser. The Veggie Meter® is a non-invasive device that measures skin carotenoid levels using reflection spectroscopy. It shines a specific wavelength of light onto the skin (typically from an LED) and analyses the light that is absorbed and reflected. Carotenoids absorb certain wavelengths of light, and the device quantifies this absorption to determine carotenoid concentration in the skin. | Baseline to week 12 |
| D009930 |
| Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |