Effects of 100% Orange Juice on Skin Health in Women

Study Overview
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Brief Summary
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Daily consumption of Orange Juice (OJ) protects skin against UV-induced damages and wrinkling, improves skin barrier function and overall skin health by decreasing oxidative stress, inflammation, and protein glycation. The positive effects of OJ on skin appearance are associated with improvements of the stratum corneum lipidomic and skin microbiome.

Detailed Description
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There is a lack of clinical evidence on how 100% orange juice (OJ) affects skin health. Women make over 90% of the decisions on food purchases for family. Skin health is a major concern for women because skin ageing becomes visibly noticeable after age 30 due to UV exposure, oxidative stress, and collagen glycation. The investigators hypothesize that micronutrients in OJ, including vitamin C, flavanones, and carotenoids, protect skin against photoaging and wrinkling by alleviating oxidative stress, inflammation, and collagen glycation. The investigators further propose that daily OJ consumption (16 oz) will improve skin elasticity, barrier function, overall skin appearance and health. The study hypotheses will be tested in a 12-week clinical trial in 24 women aged 45-65 using a randomized, double-blinded, placebo-controlled, crossover design. Placebo will be formulated using decarbonated Fanta® orange soda to match the color, taste, and calorie content of OJ, but will contain no micronutrients. This research will measure UV-induced skin erythema, wrinkles, smoothness, roughness, elasticity, hydration, pH, melanin, and transepidermal water loss (a skin barrier index) of skin on both face and forearm. Skin strips and swabs will be collected and preserved for future assessments of skin lipids and colonized microorganisms (skin microbiome) because they are key factors affecting skin health. Positive results from this pilot trial will provide clinical evidence on the effectiveness of OJ to maintain skin health and reduce ageing. This research will be carried out by a research team with the experience and facilities for skin research.

Official Title
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A Pilot Clinical Trial to Assess the Effects of 100% Orange Juice on Skin Health in Women Using a Randomized Double-Blinded Placebo-Controlled Crossover Design

Conditions
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Skin Health

Intervention / Treatment
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* Other: Orange juice
* Other: Placebo juice (Fanta)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI (18.5-29.9) Body weight ≥110 pounds Fitzpatrick skin type 2 and 3. Exclusion Criteria: pregnancy breast-feeding impaired fasting glucose frequent alcohol use history of skin cancer sunbathing and the use of tanning bed, intake of vitamin/mineral supplements habitual high intake of fruits (≥ 2 cups daily) intake of medication that might influence the outcome of the study

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orange Juice then Placebo juice (Fanta)<br>Participants will be provided orange juice for 84 days in this arm. After 28 days wash-out period, participants will receive Fanta for 84 days. | Other: Orange juice<br>* Orange juice will be purchased commercially.<br>Other: Placebo juice (Fanta)<br>* Fanta will be purchased commercially.<br>|
| Active Comparator: Placebo (Fanta) then Orange juice<br>Participants will be provided Fanta for 84 days in this arm. After 28 days wash-out period, participants will receive Orange juice for 84 days. | Other: Orange juice<br>* Orange juice will be purchased commercially.<br>Other: Placebo juice (Fanta)<br>* Fanta will be purchased commercially.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Skin color change after UV irradiation at 84 days | Irradiation will be applied to dorsal skin (back, scapular region not typically exposed to the sun) with 2 times of minimal erythema dose using an FDA approved UVB phototherapy light and a UV light meter. At baseline, after 42 and 84 days, skin color will be measured before and 24 hours 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). | Baseline, 84 days | 
| Change from baseline skin transepidermal water loss | Skin transepidermal water loss will be measured using a Tewameter to evaluate the water barrier function of the skin. The Tewameter measures the density gradient of the water evaporation from the skin (g/h/m^2). | Baseline, 84 days | 
| Change from baseline skin erythema and melanin index | Skin erythema and melanin index will be assessed with Mexameter. These two components are mainly responsible for the color of the skin. They are measured by reflectance. | Baseline, 84 days | 
| Change from baseline skin pH plus | Skin pH will be measured using a Skin-pH-Meter. | Baseline, 84 days | 
| Change from baseline skin hydration | Skin hydration will be measured using a Skin Corneometer. | Baseline, 84 days | 
| Change in skin microbiome | For skin swabbing, a 3x3-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, 84 days | 
| Change in DNA damages | Urinary excretion of 8-oxo-2'-deoxyguanosine (8-oxo-dG) will be assessed using HPLC-MS/MS because it has been suggested as a sensitive marker for UV induced skin DNA damages. | Baseline, 84 days | 
| Change in oxidative stress | Malondialdehyde in plasma will be determined as a marker of lipid peroxidation using a photometric method. | Baseline, 84 days | 
| Change in inflammation | Plasma levels of IL-6 proteins will be analyzed as inflammation biomarkers using ELISA kits. | Baseline, 84 days | 
| Change in inflammation | Plasma levels of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits. | Baseline, 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orange Juice, Skin health