Dietary Prevention of Photodamage in Skin With Grapes

Dietary Prevention of Photodamage in Skin With Grapes: A Human Clinical Study

To assess the effect of orally administered grape powder on the sunburn reaction in humans.

Study Overview

• Status: Completed
• Conditions: Non-melanoma Skin Cancer
• Intervention / Treatment: Other: Reconstituted grape powder

Detailed Description

To determine whether oral grape powder will result in a reduction in biomarkers associated with basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs). Biomarkers taken from non-sun-exposed skin and UV-exposed skin before and after treatment will be compared.

The ultimate goal of this study will be to generate new knowledge of the photoprotective effect of grape powder on UV exposure. The results may be employed as the basis for a larger clinical trial to evaluate the potential of grapes to prevent non-melanoma skin cancers (NMSCs) and sun damage.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient age 18 and older
• Patient able to understand requirements of the study and risks involved
• Patient able to sign a consent form

Exclusion Criteria:

• Patients Fitzpatrick IV-VI
• A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
• A known history of photosensitivity disorders
• A known history of melanoma or non-melanoma skin cancers
• Those planning on going to the tanning parlors
• Using any of the photosensitizing medication
• A woman who is lactating, pregnant, or planning to become pregnant
• Patient planning on exposing the irradiated or control areas to the sun

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reconstituted grape powder; Open grape powder pouch and pour contents into volumetric measuring device. Add approximately 180 mL of water to container with grape powder. Stir for a minimum of 30 seconds and ingest.	Other: Reconstituted grape powder; To prevent UV-induced skin cancers. Each subject's will have one arm exposed to 6 separate doses of UV (J/m2) [114, 217, 343, 500, 619, 848].; Other Names: Grape powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects reporting protective effect against sunburn response to UVG and/or UVA1 following administration of dietary grape powder.	Assessment will be quantified by evaluation of a person's minimal erythema dose (MED), the smallest amount of ultraviolet (UV) required to achieve a sunburn response. 6 small areas of skin (2 inches by 2 inches) on the inner part of a person's arm will be exposed to 6 separate but increasing doses of UV. 24 hours after UV treatment, the area that received the smallest dose of UV and has a visible area of redness will be marked and the respective UV dose will be considered the MED. A desirable outcome would be if an individual's MED goes up after 2 weeks of grape treatment.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure whether dietary grape powder results in a significant (p<0.05 using parire ttest) % change in markers associated with NMSC as measured by it biomarker: ornithine decarboxylase (ODC)	Immunohistochemistry (IHC) will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated.	2 weeks
Measure whether dietary grape powder results in a significant (p<0.05 using parire ttest) % change in markers associated with NMSC as measured by it biomarker: proliferating cell nuclear antigen (PCNA)	Immunohistochemistry (IHC) will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated	2 weeks
Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Ki67	IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated	2 weeks
Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Cyclin D1	IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated	2 weeks
Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Cyclooxygenase-2 (COX-2)	IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated	2 weeks
Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: matrix metalloproteinase-7 (MMP-7)	IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated.	2 weeks
Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: matrix metalloproteinase-9 (MMP-9)	IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated	2 weeks
Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Normal p53	IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated.	2 weeks
Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Mutant p53	IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated.	2 weeks
Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Sunburnt cells	Routine histology (hematoxylin and eosin stain) will be used and the number of sunburnt cells will be quantified under the microscope. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of sunburnt cells)/(total number of patients). We will also calculate the change in the number of sunburnt cells before and after treatment if a notable difference is observed.	2 weeks
Determine whether dietary grape powder has photoprotective activities resulting in a significant change in biomarkers associated with NMSC: by biomarker: Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL)-positive cells	The number of TUNEL-positive cells, which will be fluorescent, will be quantified under the microscope. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of TUNEL-positive cells)/(total number of patients). We will also calculate the percent change TUNEL-positive cells before and after treatment if a notable difference is observed.	2 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Craig A. Elmets, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): September 27, 2018
• Study Completion (Actual): September 27, 2018

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: F140627004