Nutritional Supplement Efficacy on Cellular Protection and Skin Health in Generally Healthy Adults

NCT02525224 | Completed

• 2 other identifiers: 15-PHX-0001DCS-50-15
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy skin has been equated with a healthy diet leading to the "inside out" approach to skin health. Since the skin is the barrier to the external world, healthy skin should lead to overall better health. Conversely, the skin derives its nutrition from the internal body requiring the consumption of nutritional supplements for optimal health. This research attempts to examine skin attributes and improved appearance achieved after consumption of a state-of-the-art dietary supplement.

Conditions

Skin Health

Outcome Measures

Primary Outcomes (1)

• Cellular protection of the skin

  The primary efficacy endpoint is to determine the effects of a nutritional supplement on cellular protection of the skin induced by UV radiation in generally healthy adults as determined by a reduction in sunburn cell count following supplement ingestion for 8 weeks.

  8 weeks

Secondary Outcomes (1)

• Skin Health

  8 weeks

Study Arms (1)

Nutritional Supplement

OTHER

Proprietary nutritional supplement

Dietary Supplement: Nutritional Supplement

Interventions

Nutritional Supplement DIETARY_SUPPLEMENT

2 Hard-shell liquid capsules taken twice daily with breakfast and dinner.

Nutritional Supplement

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals must be between 40-75 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
• Individuals must present with moderate signs of aging
• Subject is willing and able to participate in all aspects of the study
• Individuals must sign informed consent, photo release consent and confidentiality agreement
• Subject eats 1 or less servings of fatty fish per week
• Subject has a BMI \> 19 and \< 30
• Subjects who have been on a stable dose of chronic use medications for at least 3 months prior to study participation
• Subjects who, in the opinion of the investigator, are free of any medical condition(s) that might affect study measures

You may not qualify if:

• Subject failure to provide informed consent
• Individuals that are being treated for cancer or have a history of facial skin cancer on the test areas
• Individuals with sunburn, moderate to pronounced suntan, even skin tones, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results
• Any disease or condition of the skin that the examining investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis
• Individuals currently taking medications which in the opinion of the investigators may interfere with the study. This would include but not be limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids) immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted), and insulin, antibiotics or other topical drugs at the test sites.
• Individuals with uncontrolled metabolic diseases such as diabetes (Type I and II), hypertension, hyperthyroidism or hypothyroidism, severe chronic asthma, immunological disorders such as HIV positive, AIDS and systemic lupus erythematosus or mastectomy for cancer involving removal of lymph nodes
• Subject is taking supplemental oral dietary/nutritional supplements containing more than 800 IU of vitamin D, 200 mg fish oil, 200 mg krill oil, 2 mg total carotenoids (lycopene, lutein, etc.) and/or 5 mg resveratrol within 30 days prior to study product administration
• Difficulty in swallowing capsules
• Women known to be pregnant, nursing or planning to become pregnant
• Individuals participating in other facial clinical studies
• Individuals who have routinely used an alpha-hydroxyl-acid (AHA) or a beta-hydroxyl-acid (BHA) containing product within two weeks or Retin-A®, Retin-A Micro®, Renova®, Differin®, Avita®, Tazorac®, or Soriatane® within one month of the study start or have taken Accutane® within one year of the study start. Individuals who have used Retinol in the last six months
• Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site
• Individuals who have had chemical peels or dermabrasion within the last six months
• Individuals with known allergies to fish oil. Individuals currently using topically applied prescription medications where the medication is applied on or near the test site
• Individuals who have sun tanned (sun or tanning beds) in the nude within the past 1 year

Sponsors & Collaborators

• Pharmanex: lead
• Dermatology Consulting Services, High Point NC: collaborator

Study Sites (1)

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Zoe D Draelos, MD

  Dermatology Consulting Services, High Point NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 17, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

US (1)