Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin

NCT03289832 | Completed

• 1 other identifier: IRB00117754
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Keywords

Sulforaphane; Curcumin; Crucera-SGS; Meriva-SF; Skin; erythema; UV; Sunburn; Inflammation; Redness; ultra-violet; sunlight

Outcome Measures

Primary Outcomes (3)

• Change in Erythema 1 Day After UV Exposure

  Brief ultraviolet (UV) exposure on small circular spots on the skin will produce erythema (reddening), to be measured with a chromameter and photographed in the days following UV exposure, both before and after subjects have ingested study supplement (Crucera SGS, Meriva 500-SF, or both), daily, for a week. These measures will be compared to erythema in the skin of the same individuals following UV exposure, but WITHOUT having ingested these supplements.

  On day 8 of intervention

• Change in Erythema 2 Days After UV Exposure

  Brief ultraviolet (UV) exposure on small circular spots on the skin will produce erythema (reddening), to be measured with a chromameter and photographed in the days following UV exposure, both before and after subjects have ingested study supplement (Crucera SGS, Meriva 500-SF, or both), daily, for a week. These measures will be compared to erythema in the skin of the same individuals following UV exposure, but WITHOUT having ingested these supplements.

  On day 9 of intervention

• Change in Erythema 3 Days After UV Exposure

  Brief ultraviolet (UV) exposure on small circular spots on the skin will produce erythema (reddening), to be measured with a chromameter and photographed in the days following UV exposure, both before and after subjects have ingested study supplement (Crucera SGS, Meriva 500-SF, or both), daily, for a week. These measures will be compared to erythema in the skin of the same individuals following UV exposure, but WITHOUT having ingested these supplements.

  On day 10 of intervention

Secondary Outcomes (8)

• Bioavailability of Supplement Metabolites in bodily fluids

  Day 7 of each phase of intervention

• Change in metabolomic profile

  Day 7 of each phase of the intervention

• Change in tissue-based RNA biomarkers of inflammation

  Up to day 8 of intervention

• Change in tissue-based protein biomarkers of inflammation

  Up to day 10 of intervention

• Change in blood-based biomarkers of inflammation

  Day 7 of each phase of the intervention

Study Arms (3)

Crucera-SGS®

ACTIVE COMPARATOR

Drug: Subjects will follow a cruciferous vegetable-free diet and will first undergo a 10 day nonintervention phase. For the second phase they will be instructed to maintain a non-cruciferous diet and to ingest daily for 10 days, Crucera-SGS® as a source of glucoraphanin which is converted to sulforaphane; 9 capsules (450 mg or 1.03 mmol GR) per day. On the 7th day of each phase, they will be asked to fast overnight, come in to the clinic, provide urine and blood, and receive a dose 2-times their M.E.D. at up to 5 sites on the upper buttocks. Following the first and third days of chromometer readings, 2 biopsies will be taken from the upper buttocks for a total of 8 skin-punch biopsies per individual.

Dietary Supplement: Crucera-SGS

Meriva 500-SF®

ACTIVE COMPARATOR

Drug: Subjects will follow a cruciferous vegetable-free diet and will first undergo a 10 day nonintervention phase. For the second phase they will be instructed to maintain a non-cruciferous diet and to ingest daily for 10 days, Meriva 500-SF® as a source of curcumin; 2 capsules (1000 mg or 2.72 mmol total curcuminoids) per day. On the 7th day of each phase, they will be asked to fast overnight, come in to the clinic, provide urine and blood, and receive a dose 2-times their M.E.D. at up to 5 sites on the upper buttocks. Following the first and third day of chromometer readings, 2 biopsies will be taken from the upper buttocks, for a total of 8 skin-punch biopsies per individual.

Dietary Supplement: Meriva 500-SF

Crucera-SGS® and Meriva 500-SF®

ACTIVE COMPARATOR

Drug: Subjects will follow a cruciferous vegetable-free diet and will first undergo a 10 day nonintervention phase. For the second phase they will be instructed to maintain a cruciferous vegetable-free diet and to ingest daily for 10 days, Crucera-SGS® as a source of glucoraphanin which is converted to sulforaphane; 9 capsules (450 mg or 1.03 mmol GR) and Meriva 500-SF® as a source of curcumin; 2 capsules (1000 mg or 2.72 mmol total curcuminoids) per day. On the 7th day of each phase, they will be asked to fast overnight, come in to the clinic, provide urine and blood, and receive a dose 2-times their M.E.D. at up to 5 sites on the upper buttocks. Following the first and third day of chromometer readings, 2 biopsies will be taken from the upper buttocks for a total of 8 skin-punch biopsies per individual.

Dietary Supplement: Crucera-SGS; Dietary Supplement: Meriva 500-SF

Interventions

Crucera-SGS DIETARY_SUPPLEMENT

Crucera-SGS is a commercially available dietary supplement. The active ingredient is glucoraphanin, a phytochemical from broccoli and it is prepared as a simple extract of broccoli seeds. Glucoraphanin is converted to sulforaphane by bacteria in the human intestines. Crucera-SGS is formulated by Thorne Research Inc. into gel-caps that make it much more convenient to deliver than having subjects eat broccoli every day.

Crucera-SGS®; Crucera-SGS® and Meriva 500-SF®

Meriva 500-SF DIETARY_SUPPLEMENT

Meriva-SF is a commercially available dietary supplement. The active ingredient is curcumin, a phytochemical from the spice, turmeric, and it is prepared as a simple extract of this plant, formulated with lipids which aid in its absorption and metabolism. Meriva-SF is formulated by Thorne Research Inc. into gel-caps that make it much more convenient to deliver than having subjects eat turmeric powder every day.

Crucera-SGS® and Meriva 500-SF®; Meriva 500-SF®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Erythema; Sunburn; Inflammation

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Photosensitivity Disorders; Burns; Wounds and Injuries; Pathologic Processes

Study Officials

• Jed W Fahey, ScD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: September 21, 2017
• Study Start: September 25, 2017
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)