NCT04861623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

April 20, 2021

Last Update Submit

November 19, 2025

Conditions

Skin Health

Keywords

Orange JuiceSkin health

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, 84 days

Secondary Outcomes (7)

  • Skin transepidermal water loss

    Baseline, 84 days

  • Skin erythema and melanin index

    Baseline, 84 days

  • Inflammation biomarkers

    Baseline, 84 days

  • Inflammation biomarkers

    Baseline, 84 days

  • oxidative stress

    Baseline, 84 days

  • +2 more secondary outcomes

Study Arms (2)

Orange Juice then Placebo juice (SunnyD)

ACTIVE COMPARATOR

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 juiceOther: Placebo juice (SunnyD)

Placebo (SunnyD) then Orange juice

ACTIVE COMPARATOR

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 juiceOther: Placebo juice (SunnyD)

Interventions

Orange juiceOTHER

Orange juice will be purchased commercially.

Orange Juice then Placebo juice (SunnyD)Placebo (SunnyD) then Orange juice
Placebo juice (SunnyD)OTHER

SunnyD beverage will be purchased commercially.

Orange Juice then Placebo juice (SunnyD)Placebo (SunnyD) then Orange juice

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI (18.5-29.9)
  • Body weight ≥110 pounds
  • Fitzpatrick skin type 2 and 3.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Science and Human Nutrition Department at University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (5)

  • 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.

    PMID: 28112913BACKGROUND

  • 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.

    PMID: 21525260BACKGROUND

  • 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.

    PMID: 16702322BACKGROUND

  • 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.

    PMID: 23748556BACKGROUND

  • 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.

    PMID: 29270120BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the identity of the beverages
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 27, 2021

Study Start

January 4, 2023

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

November 24, 2025

Record last verified: 2025-03

Locations

US(1)