Clinical trial NCT03289832: Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin
Official title: Effect of Orally Delivered Phytochemicals, Alone, and in Combination, on Aging and Inflammation-Related Effects in the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: Sulforaphane
Curcumin
Crucera-SGS
Meriva-SF
Skin
erythema
UV
Sunburn
Inflammation
Redness
ultra-violet
sunlight
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to determine, in a small number of participants, the protective effects of UV-induced skin erythema (reddening or "sunburn") following oral administration of sulforaphane, curcumin, or a combination of the two plant (diet)-based supplements. The investigators will be using the over-the-counter nutritional supplements Crucera-SGS and Meriva-SF to deliver the biologically stable sulforaphane precursor and a highly bioavailable formulation of curcumin. Volunteers will be challenged with UV irradiation at 2-times the minimum erythematous dose (M.E.D.) on discrete 2 cm diameter circles on the upper buttocks. Skin redness will be monitored daily using a chromometer. Biomarkers will then be evaluated in blood, urine, and skin biopsies.

Detailed description: Oral sulforaphane (SF) delivery results in systemic protection of a wide variety of organ systems which The investigators hypothesize will also include the skin, based on animal studies and preliminary evidence in human volunteers. Since The investigators have only previously evaluated the ability of topical sulforaphane application to protect skin from UV-induced erythema, the next logical step is to evaluate the ability of oral delivery to affect the skin of healthy human volunteers. Curcumin is also a potent anti-inflammatory that acts upon different biochemical pathways from SF, and it is an antioxidant. It was discovered over a century ago, it has been the subject of well over a hundred clinical studies, and it has been an ingredient in common foods eaten by millions of people, for centuries. Before and after consumption of each of these common food ingredients, The investigators will: (a) measure the Phase 2 cytoprotective response in human skin, (b) determine whether it leads to reduced UV-induced erythema (reduced inflammation), (c) evaluate changes in age-related markers such as dermal elasticity, keratin and collagen levels, (d) measure advanced glycation end-products (AGEs) in the serum, as biomarkers of systemic (including the skin) reduction in AGE levels, and (e) measure the levels of these biomarkers in skin punch biopsies. The investigators will also evaluate the effects of combined oral SF and curcumin. The investigators anticipate that there may be a true synergistic response between SF and curcumin, and the experiments designed herein are designed to show that synergy, if it exists.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old, healthy
* Willingness to avoid sun exposure to study site
* Willingness to adhere to cruciferous vegetable-free diet

Exclusion Criteria:

* Use of photosensitizing medications
* Use of medications that cause skin flushing
* Use of anticoagulants/antiplatelet therapies
* Allergies to anesthetic agents
* Use of systemic retinoids or steroids (excluding female contraceptives and levothyroxin)
* Topical retinoids or steroids at study sites
* Antibiotic use
* Current students of the Principal Investigator
* Procedures performed at the study sites
* Smokers/tobacco users

Primary outcomes:
measure: Change in Erythema 1 Day After UV Exposure
timeFrame: On day 8 of intervention
measure: Change in Erythema 2 Days After UV Exposure
timeFrame: On day 9 of intervention
measure: Change in Erythema 3 Days After UV Exposure
timeFrame: On day 10 of intervention
Secondary outcomes:
measure: Bioavailability of Supplement Metabolites in bodily fluids
timeFrame: Day 7 of each phase of intervention
measure: Change in metabolomic profile
timeFrame: Day 7 of each phase of the intervention
measure: Change in tissue-based RNA biomarkers of inflammation
timeFrame: Up to day 8 of intervention
measure: Change in tissue-based protein biomarkers of inflammation
timeFrame: Up to day 10 of intervention
measure: Change in blood-based biomarkers of inflammation
timeFrame: Day 7 of each phase of the intervention
measure: Change in urine-based biomarkers of inflammation
timeFrame: Day 7 of each phase of the intervention
measure: Change in RNA markers of aging and protection from UV damage
timeFrame: Up to day 8 of intervention
measure: Change in protein and small-molecule markers of aging and protection from UV damage
timeFrame: Up to day 10 of intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jed W Fahey, ScD
role: PRINCIPAL_INVESTIGATOR
References: