- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183920
To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women
June 5, 2023 updated by: University of Florida
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lindsey Morgan Christman
- Phone Number: 352-294-3731
- Email: lchristman@ufl.edu
Study Contact Backup
- Name: Liwei Gu, PhD
- Email: Lgu@ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Recruiting
- Food Science and Human Nutrition Department at University of Florida
-
Contact:
- Lindsey Morgan Christman
- Phone Number: (352)-294-3731
- Email: lchristman@ufl.edu
-
Contact:
- Liwei Gu, Ph.D.
- Phone Number: (352)-294-3730
- Email: Lgu@ufl.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.
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
|
cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.
apple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 28 days
|
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
|
Baseline, 28 days
|
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.
|
Baseline, 28 days
|
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.
|
Baseline, 28 days
|
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.
|
Baseline, 28 days
|
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.
|
Baseline, 28 days
|
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
|
Baseline, 28 days
|
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
|
baseline, 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Liwei Gu, PhD, University of Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2020
Primary Completion (Estimated)
February 3, 2026
Study Completion (Estimated)
February 3, 2026
Study Registration Dates
First Submitted
November 22, 2019
First Submitted That Met QC Criteria
December 2, 2019
First Posted (Actual)
December 3, 2019
Study Record Updates
Last Update Posted (Actual)
June 6, 2023
Last Update Submitted That Met QC Criteria
June 5, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRB201903250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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