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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin Health Other: Cranberry juice Other: Placebo juice Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women
Actual Study Start Date : February 7, 2020
Estimated Primary Completion Date : February 3, 2023
Estimated Study Completion Date : February 3, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183920


Contacts
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Contact: Lindsey Morgan Christman 352-294-3731 lchristman@ufl.edu
Contact: Liwei Gu, PhD Lgu@ufl.edu

Locations
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United States, Florida
Food Science and human nutrition department at University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Lindsey Morgan Christman    (352)-294-3731    lchristman@ufl.edu   
Contact: Liwei Gu, Ph.D.    (352)-294-3730    Lgu@ufl.edu   
Sponsors and Collaborators
University of Florida
Ocean Spray, Inc.
Investigators
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Principal Investigator: Liwei Gu, PhD University of Florida
More Information
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Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04183920    
Other Study ID Numbers: IRB201903250
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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