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

July 15, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Food Science and human nutrition department at University of Florida

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ocean Spray, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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