An interventional study of Orange juice and Placebo juice (SunnyD) in Skin Health, sponsored by University of Florida. Completed at 1 site in United States. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by University of Florida · Not applicable, Interventional, and Basic science
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.
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 SunnyD orange-flavered beverage to match the color, taste, and calorie content of OJ. 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.
University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
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 · Other: Placebo juice (SunnyD)
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 · Other: Placebo juice (SunnyD)
Orange juice will be purchased commercially.
SunnyD beverage will be purchased commercially.
Skin UV sensitivity
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. The a\*-value (red/green-axis) is a measure of reddening (erythema).
Time frame: Baseline, 84 days
Skin transepidermal water loss
Skin transepidermal water loss will be measured using a Tewameter to evaluate the water barrier function of the skin.
Time frame: Baseline, 84 days
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.
Time frame: Baseline, 84 days
Inflammation biomarkers
Plasma levels of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits.
Time frame: Baseline, 84 days
Inflammation biomarkers
Plasma levels of IL-6 proteins will be analyzed as inflammation biomarkers using ELISA kits.
Time frame: Baseline, 84 days
oxidative stress
Malondialdehyde in plasma will be determined as a marker of lipid peroxidation using a photometric method.
Time frame: Baseline, 84 days
skin hydration
Skin hydration will be measured using a Skin Corneometer.
Time frame: Baseline, 84 days
skin pH
Skin pH will be measured using a Skin-pH-Meter.
Time frame: Baseline, 84 days
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Florida