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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04183920
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : September 16, 2022
Sponsor:
Collaborator:
Ocean Spray, Inc.
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE November 22, 2019
First Posted Date  ICMJE December 3, 2019
Last Update Posted Date September 16, 2022
Actual Study Start Date  ICMJE February 7, 2020
Estimated Primary Completion Date February 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Skin Health
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 3, 2023
Estimated Primary Completion Date February 3, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lindsey Morgan Christman 352-294-3731 lchristman@ufl.edu
Contact: Liwei Gu, PhD Lgu@ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04183920
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Florida
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Florida
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ocean Spray, Inc.
Investigators  ICMJE
Principal Investigator: Liwei Gu, PhD University of Florida
PRS Account University of Florida
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP