Effects of 100% Orange Juice on Skin Health in Women

NCT ID: NCT04861623

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-04

Study Completion Date

2025-10-31

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 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.

Conditions

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Skin Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will be blinded to the identity of the beverages

Study Groups

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Orange Juice then Placebo juice (SunnyD)

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.

Group Type ACTIVE_COMPARATOR

Orange juice

Intervention Type OTHER

Orange juice will be purchased commercially.

Placebo juice (SunnyD)

Intervention Type OTHER

SunnyD beverage will be purchased commercially.

Placebo (SunnyD) then Orange juice

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.

Group Type ACTIVE_COMPARATOR

Orange juice

Intervention Type OTHER

Orange juice will be purchased commercially.

Placebo juice (SunnyD)

Intervention Type OTHER

SunnyD beverage will be purchased commercially.

Interventions

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Orange juice

Orange juice will be purchased commercially.

Intervention Type OTHER

Placebo juice (SunnyD)

SunnyD beverage will be purchased commercially.

Intervention Type OTHER

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Food Science and Human Nutrition Department at University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Li R, Kim MH, Sandhu AK, Gao C, Gu L. Muscadine Grape (Vitis rotundifolia) or Wine Phytochemicals Reduce Intestinal Inflammation in Mice with Dextran Sulfate Sodium-Induced Colitis. J Agric Food Chem. 2017 Feb 1;65(4):769-776. doi: 10.1021/acs.jafc.6b03806. Epub 2017 Jan 23.

Reference Type BACKGROUND
PMID: 28112913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21525260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16702322 (View on PubMed)

Heckman CJ, Chandler R, Kloss JD, Benson A, Rooney D, Munshi T, Darlow SD, Perlis C, Manne SL, Oslin DW. Minimal Erythema Dose (MED) testing. J Vis Exp. 2013 May 28;(75):e50175. doi: 10.3791/50175.

Reference Type BACKGROUND
PMID: 23748556 (View on PubMed)

Manippa V, Padulo C, van der Laan LN, Brancucci A. Gender Differences in Food Choice: Effects of Superior Temporal Sulcus Stimulation. Front Hum Neurosci. 2017 Dec 7;11:597. doi: 10.3389/fnhum.2017.00597. eCollection 2017.

Reference Type BACKGROUND
PMID: 29270120 (View on PubMed)

Other Identifiers

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IRB202100814

Identifier Type: -

Identifier Source: org_study_id

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