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Effects of 100% Orange Juice on Skin Health in Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04861623
Enrollment
20
Registered
2021-04-27
Start date
2023-01-04
Completion date
2025-10-31
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Health

Keywords

Orange Juice, Skin health

Brief summary

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

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.

Interventions

OTHEROrange juice

Orange juice will be purchased commercially.

OTHERPlacebo juice (SunnyD)

SunnyD beverage will be purchased commercially.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participants will be blinded to the identity of the beverages

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Skin UV sensitivityBaseline, 84 daysIrradiation 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).

Secondary

MeasureTime frameDescription
Skin erythema and melanin indexBaseline, 84 daysSkin 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.
Inflammation biomarkersBaseline, 84 daysPlasma levels of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits.
Skin transepidermal water lossBaseline, 84 daysSkin transepidermal water loss will be measured using a Tewameter to evaluate the water barrier function of the skin.
skin hydrationBaseline, 84 daysSkin hydration will be measured using a Skin Corneometer.
skin pHBaseline, 84 daysSkin pH will be measured using a Skin-pH-Meter.
oxidative stressBaseline, 84 daysMalondialdehyde in plasma will be determined as a marker of lipid peroxidation using a photometric method.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026