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Completed

NCT Number: NCT04861623

Effects of 100% Orange Juice on Skin Health in Women

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.

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Key information

Conditions

Skin Health

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Food Science and Human Nutrition Department at University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orange juice

Other

Orange juice will be purchased commercially.

Placebo juice (SunnyD)

Other

SunnyD beverage will be purchased commercially.

Primary outcomes

  1. Skin UV sensitivity

    Time frame: Baseline, 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. The a*-value (red/green-axis) is a measure of reddening (erythema).

Secondary outcomes

  1. Skin transepidermal water loss

    Time frame: Baseline, 84 days

    Skin transepidermal water loss will be measured using a Tewameter to evaluate the water barrier function of the skin.

  2. Skin erythema and melanin index

    Time frame: Baseline, 84 days

    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.

  3. Inflammation biomarkers

    Time frame: Baseline, 84 days

    Plasma levels of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits.

  4. Inflammation biomarkers

    Time frame: Baseline, 84 days

    Plasma levels of IL-6 proteins will be analyzed as inflammation biomarkers using ELISA kits.

  5. oxidative stress

    Time frame: Baseline, 84 days

    Malondialdehyde in plasma will be determined as a marker of lipid peroxidation using a photometric method.

  6. skin hydration

    Time frame: Baseline, 84 days

    Skin hydration will be measured using a Skin Corneometer.

  7. skin pH

    Time frame: Baseline, 84 days

    Skin pH will be measured using a Skin-pH-Meter.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2021
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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