Skin HealthNCT04183920
To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women
A study testing Cranberry juice in people with Skin Health, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Cranberry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2020to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- BMI (18.5-29.9)
- Body weight ≥110 pounds
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Science and human nutrition department at University of Florida
Gainesville, Florida, 32611
About this study
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.
Read the 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.
- Conditions
- Skin Health
- Being tested
- Cranberry juice, Placebo juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry juiceOther
cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.
Placebo juiceOther
apple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 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. Receives: Other: Cranberry juice; Other: Placebo juice |
| Group B | Active comparator | 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 Receives: Other: Cranberry juice; Other: Placebo juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Skin color change after UV irradiation at 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.
Measured: Baseline, 28 days
Change from baseline Skin transepidermal water loss
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
Measured: Baseline, 28 days
Change from baseline SELS parameters
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.
Measured: Baseline, 28 days
Change in skin microbiome
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.
Measured: Baseline, 28 days
Change in baseline skin pH
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.
Measured: Baseline, 28 days
Change from baseline hydration
Skin hydration will be measured with a Corneometer (CK Electronic GmbH, Germany. This is a handheld probe that allows for quick and easy measurements.
Measured: Baseline, 28 days
Change in Skin erythema and melanin index
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
Measured: Baseline, 28 days
Change in skin lipidome
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
Measured: baseline, 28 days
Secondary outcomes (1)
Survival rate of human keratinocyte under UV light
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start7 Feb 2020
- Primary completion31 Jul 2023
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ocean Spray, Inc.
- Responsible party
- Sponsor
- Investigators
- Liwei Gu, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183920
- Sponsor's protocol ID
- IRB201903250
- Status last verified
- Jul 2024
- First submitted
- 22 Nov 2019
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22211895Liu 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.
PubMed 21826359Heinrich 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.
PubMed 21525260Heinrich 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.
PubMed 16702322
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women
- ClinicalTrials.gov ID
- NCT04183920
- Acronym / sponsor ID
- IRB201903250
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Ocean Spray, Inc.
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Cranberry juice, Other: Placebo juiceParticipants 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. |
| Group B | Active comparator | Other: Cranberry juice, Other: Placebo juiceParticipants 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- BMI (18.5-29.9)
- Body weight ≥110 pounds
Key exclusion criteria (7 listed)
- Skin Cancer
- Smokers and frequent alcohol use
- Pregnancy
- Breast-feeding
- intake of medication that might influence the outcome of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry juicecranberry juice cocktail provided by Ocean Spray Cranberries, Inc. | Other | Group A, Group B |
| Placebo juiceapple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc. | Other | Group A, Group B |
Primary outcome
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
1 secondary outcome
Survival rate of human keratinocyte under UV light
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 22211895Ramasamy 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.
- Background: PubMed 21826359Liu 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.
- Background: PubMed 21525260Heinrich 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.
- Background: PubMed 16702322Heinrich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liwei Gu, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry juice in people with Skin Health, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Skin color change after UV irradiation at 28 days (time frame: Baseline, 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183920, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.