Ageing Signs, Healthy Volunteer, Skin Condition
Conditions
Keywords
females, Skin Health, Carotenoids
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCarotenoids
CaroRite capsule containing carotenoids with sunflower oil. 1 capsule to be taken each day for 12 weeks.
OTHERPlacebo
Placebo capsule containing sunflower oil. 1 capsule to be taken each day for 12 weeks.
Sponsors
RDC Clinical Pty Ltd
Bio-Gen Extracts Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Females 40-55 years (inclusive) * Generally healthy * BMI 18.5-29.9 kg/m2 (inclusive) * Able to provide informed consent * Agree not to change regular skincare routine * Agree to not participate in another clinical trial while enrolled in this trial * Agree to not significantly change current diet and/or exercise frequency or intensity during study period
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. * Medications for acne or other skin conditions including topical retinoids (Rein-A, Retrieve) oral retinoids such as Isotretinoin (Roaccutane), benzoyl peroxide, AHA's, serum, chemical peels within 1 month prior to screening. * Currently taking carotenoid supplements (Beta-Carotene, Lycopene, Lutein, Zeaxanthin, Astazanthin) * Active smokers, nicotine use or drug (prescription or illegal substances) abuse * Chronic past and/or current alcohol use (\>14 alcoholic drinks week) * Pregnant or lactating women * Allergic to any of the ingredients in active or placebo formula * Participants who are currently participating in any other clinical trial or who have participated in a clinical trial that may affect skin health during the past 1 month * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to the end of the study period in Visible signs of ageing | Baseline to week 12 | 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: * Skin elasticity * Hydration * Wrinkle depth and type * Sebum * pigmentation * Skin pH and temperature |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to the end of the study period in Transepidermal water loss (TEWL) | Baseline to week 12 | 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. |
| Change from baseline to the end of the study period in Skin collagen thickness | Baseline to week 12 | 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. |
| Change from baseline to the end of the study period in Skin carotenoid analysis | Baseline to week 12 | 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. |
| Change from baseline to the end of the study period in Safety and adverse events | Baseline to week 12 | 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. |
| Change from baseline to the end of the study period in Participant self-assessment of product effectiveness | Baseline to week 12 | 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 |
| Change from baseline to the end of the study period in Self-administered carotenoid intake questionnaire | Baseline to week 12 | 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. |
| Change from baseline to the end of the study period in 24-hour diet recall | Baseline to week 12 | Change from baseline to the end of the study period in 24-hour diet recall |
| Skin carotenoid analysis (Veggie Metre) | Baseline to week 12 | 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. |
Countries
Australia
Contacts
STUDY_DIRECTORSalman Mehkri
Bio-gen Extracts
Outcome results
None listed