To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women

• ClinicalTrials.gov Identifier: NCT04183920
• Recruitment Status: Recruiting
• First Posted: December 3, 2019
• Last Update Posted: September 16, 2022
• Sponsor: University of Florida
• Collaborator: Ocean Spray, Inc.
• Information provided by (Responsible Party): University of Florida

Tracking Information

• First Submitted Date: November 22, 2019
• First Posted Date: December 3, 2019
• Last Update Posted Date: September 16, 2022
• Actual Study Start Date: February 7, 2020
• Estimated Primary Completion Date: February 3, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2020)

• Change from baseline Skin color change after UV irradiation at 28 days [ Time Frame: Baseline, 28 days ]
  Irradiation will be applied to dorsal skin (region not typically exposed to the sun) using an FDA approved UVB phototherapy light and a UV light meter. At each assessment, skin color will be measured before and 24 h after irradiation. Skin color will be evaluated by a colorimeter using the 3-dimensional color system with L-, a-, and b-values. L- and b- values assess lightness and browning effects, respectively. The a-value (red/green-axis) is a measure for reddening (erythema). The Δa-values (a-value 24 h after irradiation minus a-value before irradiation) will compared between baseline through 3 months; decreasing Δa-values indicates a photoprotective effect.
• Change from baseline Skin transepidermal water loss [ Time Frame: Baseline, 28 days ]
  Skin transepidermal water loss an will be measured using a Tewameter (CK Electronic GmbH, Germany). This is a handheld probes that allow for quick and easy measurements
• Change from baseline SELS parameters [ Time Frame: Baseline, 28 days ]
  SELS (Surface evaluation of the Living Skin) parameters, including smoothness, roughness, scaliness, and wrinkles, will be determined using a Visioscan VC20. This hand-hold device scans a 1 cm x 1 cm skin area (https://www.courage-khazaka.de/en/scientific-products/all-products/imaging/16-wissenschaftliche-produkte/alle-produkte/150-visioscan-e). Visioscan VC20 scanner consists of a camera, a high- resolution video sensor, and a UVA light no hazardous to human skin.
• Change in skin microbiome [ Time Frame: Baseline, 28 days ]
  For skin swabbing, a 4x4-cm square on a forearm will be swabbed with a cotton swab soaked in 0.9% sodium chloride with 0.1% Tween-20 in a Z-stroke manner.
• Change in baseline skin pH [ Time Frame: Baseline, 28 days ]
  Skin pH will be assessed using a skin pH meter (CK Electronic GmbH, Germany). This is a handheld probes that allow for quick and easy measurements.
• Change from baseline hydration [ Time Frame: Baseline, 28 days ]
  Skin hydration will be measured with a Corneometer (CK Electronic GmbH, Germany. This is a handheld probe that allows for quick and easy measurements.
• Change in Skin erythema and melanin index [ Time Frame: Baseline, 28 days ]
  Skin erythema and melanin index will be assessed with a Mexameter, (CK Electronic GmbH, Germany). Each of these are handheld probes that allow for quick and easy measurements
• Change in skin lipidome [ Time Frame: baseline, 28 days ]
  Stratum corneum layer on forearm skin will be sampled with 16 D-squame® tapes using a standard noninvasive tape stripping technique. This will be sent for lipidomic analysis

Original Primary Outcome Measures (submitted: December 2, 2019)

• Change from baseline Skin color change after UV irradiation at 28 days [ Time Frame: Baseline, 28 days ]
  Irradiation will be applied to dorsal skin (region not typically exposed to the sun) using an FDA approved UVB phototherapy light and a UV light meter. At each assessment, skin color will be measured before and 24 h after irradiation. Skin color will be evaluated by a colorimeter using the 3-dimensional color system with L-, a-, and b-values. L- and b- values assess lightness and browning effects, respectively. The a-value (red/green-axis) is a measure for reddening (erythema). The Δa-values (a-value 24 h after irradiation minus a-value before irradiation) will compared between baseline through 3 months; decreasing Δa-values indicates a photoprotective effect.
• Change from baseline Skin transepidermal water loss at 28 days [ Time Frame: Baseline, 28 days ]
  Using Aquaflux (BioX systems Ltd) measuring water vapour flux density (, the unit is g*m^(-2)*h^(-1).)
• Change from baseline Skin erythema and melanin index water loss at 28 days [ Time Frame: Baseline, 28 days ]
  Index increases as the skin becomes more erythematous and more pigmented, respectively, so the melanin index (M-index) can be regarded as a parameter which is mainly influenced by the melanin content.

Current Secondary Outcome Measures (submitted: December 2, 2019)

Survival rate of human keratinocyte under UV light [ Time Frame: 24 hours ]

The immortalized human keratinocyte cell line (HaCaT) will be cultured in Dulbecco's Modified Eagle Medium. Cells will be incubated with human serum collected after 2-hour and 4-hour cranberry juice intake or water intake for 24 hours.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women
• Official Title: To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women
• Brief Summary: Previous studies have shown that cranberry phytochemicals scavenge reactive carbonyls. Cranberry polyphenols have been reported to attenuate collagen degradation and inhibit oxidative stress in human cells. We hypothesize that cranberry juice consumption will attenuate skin photoaging and improve skin health in women via alleviate oxidative stress.
• Detailed Description: One of the causative factors of skin ageing is cumulative oxidative damages due to aerobic metabolism and UV irradiation. Cumulation of reactive oxygen species (ROS) causes collagen glycation and crosslinking which are direct causes of skin ageing. Previous studies have shown that cranberry phytochemicals scavenge reactive carbonyls. Cranberry polyphenols have been reported to attenuate collagen degradation and inhibit oxidative stress in human cells. It is unknown whether cranberry juice consumption could protect against UV -induced erythema and improve overall skin health. Furthermore, if it does have effect, what will be the mechanism? This human intervention study will be conducted to answer these questions. We hypothesize that cranberry juice consumption will attenuate skin photoaging and improve skin health in women via alleviate oxidative stress.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Skin Health

Intervention

• Other: Cranberry juice
  cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.
• Other: Placebo juice
  apple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc.

Study Arms

• Active Comparator: Group A
  Participants in this arm will be provided cranberry juice to consume for 42 days in total. After a 10-21-day washout period participants will receive placebo juice for 42 days.
  Interventions:

  • Other: Cranberry juice
  • Other: Placebo juice
• Active Comparator: Group B
  Participants in this arm will be provided placebo juice to consume for 42 days in total. After a 10-21-day washout period participants will receive cranberry juice to consume for 42 days
  Interventions:

  • Other: Cranberry juice
  • Other: Placebo juice

Publications *

• Ramasamy R, Yan SF, Schmidt AM. Receptor for AGE (RAGE): signaling mechanisms in the pathogenesis of diabetes and its complications. Ann N Y Acad Sci. 2011 Dec;1243:88-102. doi: 10.1111/j.1749-6632.2011.06320.x.
• Liu H, Liu H, Wang W, Khoo C, Taylor J, Gu L. Cranberry phytochemicals inhibit glycation of human hemoglobin and serum albumin by scavenging reactive carbonyls. Food Funct. 2011 Aug;2(8):475-82. doi: 10.1039/c1fo10087d. Epub 2011 Aug 8.
• Heinrich U, Moore CE, De Spirt S, Tronnier H, Stahl W. Green tea polyphenols provide photoprotection, increase microcirculation, and modulate skin properties of women. J Nutr. 2011 Jun;141(6):1202-8. doi: 10.3945/jn.110.136465. Epub 2011 Apr 27.
• Heinrich U, Neukam K, Tronnier H, Sies H, Stahl W. Long-term ingestion of high flavanol cocoa provides photoprotection against UV-induced erythema and improves skin condition in women. J Nutr. 2006 Jun;136(6):1565-9. doi: 10.1093/jn/136.6.1565.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 2, 2019): 22
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 3, 2023
• Estimated Primary Completion Date: February 3, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy
• BMI (18.5-29.9)
• Body weight ≥110 pounds

Exclusion Criteria:

• Skin Cancer
• Smokers and frequent alcohol use
• Pregnancy
• Breast-feeding
• intake of medication that might influence the outcome of the study
• sunbathing or the use of tanning bed
• intake of vitamin/mineral supplements

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Lindsey Morgan Christman; 352-294-3731; lchristman@ufl.edu

Contact: Liwei Gu, PhD; Lgu@ufl.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04183920
• Other Study ID Numbers: IRB201903250
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Florida
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Florida
• Original Study Sponsor: Same as current
• Collaborators: Ocean Spray, Inc.

Investigators

• Principal Investigator: Liwei Gu, PhD; University of Florida

• PRS Account: University of Florida
• Verification Date: September 2022