A randomized, double-blind, placebo-controlled study to investigate the effects of OmniActive Lutemax 2020® oil suspension on skin health attributes

ISRCTN	ISRCTN15646478
DOI	https://doi.org/10.1186/ISRCTN15646478
Secondary identifying numbers	OAHT002-2013 (CS920113)

Submission date: 31/07/2015
Registration date: 24/08/2015
Last edited: 31/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Lutein and zeaxanthin are naturally occurring compounds called carotenoids. They have both been shown to reduce the risk of cataracts and age-related macular degeneration (a condition whereby the sufferer loses their central vision, usually gradually over a period of time). Lutemax™ 2020 is a product enriched with lutein and zeaxanthin taken from Marigold flowers. This study investigates the effects of Lutemax™ 2020 (10 mg/day) when compared to a placebo for 12 weeks on the skin including lightening, hydration, roughness levels and elasticity and also to study its effects on photo damage.

Who can participate?
Adults aged 18-45 with certain skin tones and happy to follow the dietary restrictions involved.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given a dietary supplement containing carotenoids (Lutemax™ 2020 containing 10 mg L and 2 mg Zeaxanthin isomers) or a placebo (safflower oil) taken orally (with water, after breakfast) once a day. Skin health attributes will be measured such as skin color, skin tone, hydration and elasticity are then measured for all participants in each group and compared.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
TKL Research Center, New Jersey, USA

When is the study starting and how long is it expected to run for?
March 2014 to February 2015

Who is funding the study?
OmniActive Health Technologies Inc.

Who is the main contact?
Dr Vijaya Juturu
v.juturu@omniactives.com

Contact information

Dr Vijaya Juturu
Scientific

OmniActive Health Technologies Inc.
67 East Park Place
Suite 500
Morristown, New Jersey
07960
United States of America

ORCID ID	0000-0002-7397-715X
Phone	18665883629307
Email	v.juturu@omniactives.com

Study information

Study design	Randomized double-blind matched-pair placebo-controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	The effects of oral supplementation of lutein and zeaxanthin isomers (Lutemax2020®) on skin color and skin tone: a double-blind and placebo-controlled clinical trial
Study objectives	Carotenoids especially lutein and zeaxanthin isomers (RR-zeaxanthin and RS-zeaxanthin) possess absorption spectra in both in the UVB and UVA range, and are able to block the formation of melanin pathways and melanin in melanocytes, decreases inflammatory cytokines and increases anti-oxidant properties. Lutein is one of the carotenoids that is present in high concentrations in skin cells. Hence we examined the effects of lutein and zeaxanthin isomers effect on skin color and skin tone.
Ethics approval(s)	IntegReview (USA), 03/02/2014, ref: OAHT002-2013 (TKL No. CS920113)
Health condition(s) or problem(s) studied	Skin health
Intervention	Lutemax2020® (containing 10 mg lutein and 2 mg zeaxanthin isomers) or a placebo (safflower oil) taken orally once a day.
Intervention type	Supplement
Primary outcome measure	1. Skin color 2. Skin tone 3. Photoprotective activity 4. Hydration 5. TEWL 6. Subjective assessments for skin health
Secondary outcome measures	Blood analysis such as lutein and zeaxanthin isomers
Overall study start date	30/03/2014
Completion date	15/02/2015

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Both
Target number of participants	48
Key inclusion criteria	1. Healthy, pre-menopausal females aged 18 to 45 years 2. Healthy males aged 18-45 years 3. Subjects with mild to moderate dry skin (to be determined by the Investigator). 4. Fitzpatrick Skin Type II –IV scale 5. Non-smokers 6. A body mass index (BMI) of 20 to 34 kg/m2 7. Normal values, based on the opinion of investigator, for the following assays: clinical chemistry, hematology, and urinalysis 8. Willing to avoid lutein/zeaxanthin rich foods and follow the dietary restriction list provided by the PI during the study and for 10 days prior to enrollment 9. Subjects are willing to avoid prolonged exposure to UV radiation and sun bath for the duration of the study 10. Willingness to complete all clinic visits and to complete all diaries/records associated with the study 11. Willingness to avoid cosmetics (excluding sunscreen) and cosmetic procedures (i.e., chemical peels, microdermabrasion, laser treatment) that may affect the skin on the forearms and face. 12. Willingness to use only the provided body wash and body cream for the entire 12-week study duration and to follow specific instructions related to their use on study visit days. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid 13. Able to provide informed consent 14. Willingness not to apply regularly used make-up during each study visit
Key exclusion criteria	1. Subjects with moderate or severe acne. 2. Subjects who have participated in a clinical study in which they used Retin-A or a retinoid, alpha-hydroxy acids, salicylic acid or vitamin C for 3 months prior to enrollment. 3. Subjects currently using any topical medication on the face. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha hydroxy acids, salicylic acid, vitamin C, retinol and retinoid. 4. History of, or current disease or condition of the skin that the investigator deems inappropriate for study participation (eg, atopic skin, acne vulgaris, facial scars, psoriasis, eczema, other scaly inflammatory diseases). 5. History of, or current diagnosis of uncontrolled chronic conditions eg liver, kidney, pulmonary, gastrointestinal, cardiovascular, pancreatic and/or immune diseases[1] (3 months on stable pharmacological treatment is acceptable). 6. History of, or current diagnosis of, cancer[1]. 7. Diagnosed with hyperthyroidism or hypothyroidism[1]. 8. Positive narcotics (urinalysis) or alcohol screen (breathalyzer). 9. Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 months from baseline or plan to have a treatment during the study. 10. Subjects using an alpha-hydroxy acid containing products within 3 months of enrollment. Continued use of current facial moisturizers and cleansers will be acceptable, but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid. 11. Subjects currently using a salicylic acid containing product on the face (including astringents and toners) 3 months prior to enrollment. Continued use of current facial moisturizers and cleansers will be acceptable but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid. 12. Subjects currently using or have used products containing retinol or retinoid on the face (including moisturizers) 3 months prior to enrollment. Continued use of current facial moisturizers and cleansers will be acceptable, but cannot contain alpha-hydroxy acids, salicylic acid, vitamin C, retinol and retinoid. 13. Subjects currently under a physician’s care for a skin problem. 14. Taking any medication that could affect skin (eg, Tetracycline). 15. Recent sunburn or having peeling due to sunburn within 2 weeks of enrollment. 16. Taking vacation involving photo exposure (beaches or skiing) during the study. 17. Subjects have used tretinoin, adapalene, tazarotene or other topical retinoid medications for the treatment of facial skin aging 3 months prior to enrollment and during the study. 18. Subjects have used or plan to use systemic corticosteroids within 30 days of enrollment or during the study. 19. Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin (eg, antioxidants, anti-aging retinoids, antibiotics, corticosteroids) within one month of enrollment. 20. Subjects have a history of severe alcohol consumption or drug abuse in the past year (obtained through Medical History). 21. Subjects are participating in another interventional study. 22. Positive pregnancy test in women of child-bearing potential. 23. Pregnant or breast-feeding or planning on becoming pregnant. 24. Women of child-bearing potential not using effective non-hormonal contraception. 25. Use of lutein supplements or multivitamin supplements or cosmetics containing lutein or multivitamin providing more than 1 mg of lutein per day within 10 days of enrollment.
Date of first enrolment	30/03/2014
Date of final enrolment	30/04/2014

Locations

Countries of recruitment

United States of America

Study participating centre

TKL Research Center

365 W Passaic St #550
Rochelle Park
New Jersey
07662
United States of America

Sponsor information

OmniActive Health Technologies Inc
Industry

67 East Park Place
Suite 500
Morristown, New Jersey
07960
United States of America

Phone	+001 8665883629307
Email	v.juturu@omniactives.com
Website	http://www.omniactives.com
"ROR"	https://ror.org/024e1pj18

Funders

Funder type

Industry

OmniActive Health Technologies
Private sector organisation / For-profit companies (industry)

Location: United States of America

Results and Publications

Intention to publish date	30/12/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/10/2016		Yes	No

Editorial Notes

31/07/2018: Publication reference added.