Lumenato Nutritional Supplement on Skin Appearance | NCT04248699

Status Module

Name	Class
ObvioHealth	INDUSTRY

Label	Type	Description	Intervention Names
Lumenato Supplement	Experimental	tomato oleoresin	Dietary Supplement: Lumenato

Name	Type	Description	Arm Group Labels	Other Names
Lumenato	Dietary Supplement	tomato oleoresin obtained from yellow dry tomato pulp	Lumenato Supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™	FACE-Q™ Satisfaction with Skin scale: gathers the participant perspective of their satisfaction or dissatisfaction with their facial skin using a 12-question scale. Participants are asked to choose one of the following responses for each question: Very Dissatisfied (1), Somewhat Dissatisfied (2), Somewhat Satisfied (3) and Very Satisfied (4) for each 12 questions and the sum of scores (or mean of the completed items, in the event of an incomplete scale) gets converted into a score from 0 (worst) to 100 (best).	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Baseline Skin Questionnaire	Participant perception of change or maintenance in a variety of skin health parameters over the course of the study using the subjective "Baseline Skin Questionnaire"	12 weeks
End of Study Product Questionnaire"

Other Outcomes

Measure	Description	Time Frame
Adverse events (AEs) observed during the study, classified by the investigator as to severity, relationship to the study product/protocol, and seriousness	classified by the investigator	14 weeks
Compliance to the daily use of the Lycored Lumenato supplement through monitoring within ClaimIt (Weekly e-Diary)

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Resides in the United States
Generally healthy women between the ages of 35-55
Fitzpatrick skin types 2 or 3
Identifies as one of the following: Asian, White, Hispanic/Latino, or both White and Hispanic/Latino
Type 2 on the Glogau Skin Classification scale
Has expressed interest in improving skin health and appearance
Willing and able to follow the procedures of the study
Willing to refrain from changing their diet or lifestyle significantly for the duration of the study
Able to understand the study requirements and activities in English, and provide informed consent
Access to reliable internet service and smartphone in order to utilize the ClaimIt software/app needed to remotely participate in the study

Exclusion Criteria:

Participants with Fitzpatrick skin types of 1, 4, 5 or 6
Known allergies or sensitivity to tomato, latex and/or potato
Current use or use within 1 month of study enrollment of hormonal therapies (including hormonal contraceptives)
Current, regular use or regular use within 1 month of study enrollment of oral steroids; regular use defined as >10 consecutive days
Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins")
Pregnant, lactating or breastfeeding women (within the last 6 months) or those planning to become pregnant during the study period
Less than 2 years since diagnosis or treatment of skin cancer including basal cell carcinoma, squamous cell carcinoma, melanoma- excluding actinic keratosis
Currently active herpes infections or currently on treatment for herpes infections
History of facial keloids
Current diagnosis of adult acne or currently on treatment for adult acne
Recent (<6 months at enrollment) cardiovascular conditions such as stroke, transient ischemic attack (TIA), or myocardial ischemia/infarction, recently on treatment for congestive heart failure, or currently having vasculitis or vascular conditions
On potent blood thinners such as low-molecular weight heparin (LMWH), rivaroxaban, apixaban, or other prescription blood thinners - excludes aspirin
Holds a current diagnosis of diabetes mellitus type I or II
Participants who have received facial irradiation within last year or are planning on undergoing facial irradiation during the study
Chronic liver disease- excluding early stage non-alcoholic fatty liver disease (NAFLD)
Chronic kidney disease or recent (<6 months at enrollment) acute kidney disease
Participants who currently take supplements containing carotenoids, lutein, melatonin or tryptophan
Participants with occupations or lifestyle that require significant daily exposure to the sun (defined as at least 1 hour of continuous outdoor sun exposure)
Participants who have had a sunburn in the last 2 weeks
Participants who use tanning salons or tanning products in the last 3 months
Participants who plan to undergo invasive facial procedures (injections, chemical peeling, etc.) during the study or have undergone these procedures within 2 months prior to enrollment
Change in oral supplements or medications targeting skin health within 2 months prior to enrollment
Participants who are HIV positive
Participants who are immunosuppressed
Participants with a recent (<2 months prior to enrollment) diagnosis of a psychiatric condition
Participants having chronic connective tissue disorder affecting the skin (e.g. Ehlers- Danlos syndrome, Marfan's Syndrome, Osteogenesis Imperfecta)
Participants with auto-immune skin diseases (e.g. scleroderma, psoriasis, lupus, epidermolysis bullosa, bullous pemphigoid, temporal arteritis)
Participants who have been prescribed retinoids treatment (<2 months prior to enrollment)
Participants who meet either/or both of the following criteria with regards to smoking habits (smoking includes cigarettes, e-cigs, pipes, hookah, cigars):
Who are current smokers (smoked at least 100 cigarettes, or tobacco/nicotine equivalent, in her lifetime) and who continue to use these products
Who were former smokers (smoked at least 100 cigarettes, or tobacco/nicotine equivalent, in her lifetime, but who have quit smoking) who have smoked within the last year and/or were former smokers for 10 years
Participants who drink more than 14 drinks per week (more than 2 drinks per night)
Participants who use illicit or illegal drugs
Participants who are regular users of cannabis substances or substances derived from cannabis such as CBD, CBD oils or balms, cannabis-containing edibles; vaping; smoking; hookahs.
NOTE: regular use is defined as long stretches of inhaling or consuming these products over several months or longer. Occasional, but not weekly, use of products with small amounts of CBD-related compounds (e.g. waters with CBD infusions) are not considered regular use.)
Participants who are planning a trip to the mountains or to a higher UV index region during the study period
Any other medication, condition or disease that in the PI's opinion that may adversely affect the participant's ability to complete the study, substantially impact the study's integrity or may pose a significant risk to the participant
Participants who are experiencing perimenopausal or menopausal symptoms
Participants who have had a hysterectomy and/or both of their ovaries removed

PubMed Identifier	Type	Citation	Retractions
8948530	Background	Glogau RG. Aesthetic and anatomic analysis of the aging skin. Semin Cutan Med Surg. 1996 Sep;15(3):134-8. doi: 10.1016/s1085-5629(96)80003-4.
30836363	Background	Groten K, Marini A, Grether-Beck S, Jaenicke T, Ibbotson SH, Moseley H, Ferguson J, Krutmann J. Tomato Phytonutrients Balance UV Response: Results from a Double-Blind, Randomized, Placebo-Controlled Study. Skin Pharmacol Physiol. 2019;32(2):101-108. doi: 10.1159/000497104. Epub 2019 Mar 5.