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

NCT04183920 | Completed DMC

• 1 other identifier: IRB201903250
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Health

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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.

  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.

  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.

  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.

  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

  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

  baseline, 28 days

Secondary Outcomes (1)

• Survival rate of human keratinocyte under UV light

  24 hours

Study Arms (2)

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.

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

Other: Cranberry juice; Other: Placebo juice

Interventions

Cranberry juice OTHER

cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.

Group A; Group B

Placebo juice OTHER

apple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc.

Group A; Group B

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• BMI (18.5-29.9)
• Body weight ≥110 pounds

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Ocean Spray, Inc.: collaborator

Study Sites (1)

Food Science and human nutrition department at University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (4)

• 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.

  PMID: 22211895 BACKGROUND

• 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.

  PMID: 21826359 BACKGROUND

• 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.

  PMID: 21525260 BACKGROUND

• 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.

  PMID: 16702322 BACKGROUND

Study Officials

• Liwei Gu, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 3, 2019
• Study Start: February 7, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 10, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)