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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Health
• Intervention / Treatment: Other: Orange juice; Other: Placebo juice (Fanta)

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 decarbonated Fanta® orange soda to match the color, taste, and calorie content of OJ, but will contain no micronutrients. 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yavuz Yagiz, PhD; Phone Number: (352) 294-3988; Email: yavuzy@ufl.edu
• Study Contact Backup: Name: Liwei Gu, PhD; Phone Number: (352) 294-3730; Email: lgu@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • Food Science and Human Nutrition Department at University of Florida
      • Contact: Yavuz Yagiz
      • Contact: Liwe Gu
      • Principal Investigator: Liwei Gu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Orange Juice then Placebo juice (Fanta); 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; Orange juice will be purchased commercially.; Other: Placebo juice (Fanta); Fanta will be purchased commercially.
Active Comparator: Placebo (Fanta) 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.	Other: Orange juice; Orange juice will be purchased commercially.; Other: Placebo juice (Fanta); Fanta will be purchased commercially.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Skin color change after UV irradiation at 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 using the 3-dimensional color system with L*, a*, and b*-values. L* and b* values assess lightness and browning effects, respectively. The a*-value (red/green-axis) is a measure for reddening (erythema).	Baseline, 84 days
Change from baseline skin transepidermal water loss	Skin transepidermal water loss will be measured using a Tewameter to evaluate the water barrier function of the skin. The Tewameter measures the density gradient of the water evaporation from the skin (g/h/m^2).	Baseline, 84 days
Change from baseline 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.	Baseline, 84 days
Change from baseline skin pH plus	Skin pH will be measured using a Skin-pH-Meter.	Baseline, 84 days
Change from baseline skin hydration	Skin hydration will be measured using a Skin Corneometer.	Baseline, 84 days
Change in skin microbiome	For skin swabbing, a 3x3-cm square on a forearm will be swabbed with a cotton swab soaked in 0.9% sodium chloride with 0.1% Tween-20 in a Z-stroke manner.	Baseline, 84 days
Change in DNA damages	Urinary excretion of 8-oxo-2'-deoxyguanosine (8-oxo-dG) will be assessed using HPLC-MS/MS because it has been suggested as a sensitive marker for UV induced skin DNA damages.	Baseline, 84 days
Change in oxidative stress	Malondialdehyde in plasma will be determined as a marker of lipid peroxidation using a photometric method.	Baseline, 84 days
Change in inflammation	Plasma levels of IL-6 proteins will be analyzed as inflammation biomarkers using ELISA kits.	Baseline, 84 days
Change in inflammation	Plasma levels of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits.	Baseline, 84 days

Collaborators and Investigators

• Sponsor: University of Florida

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Skin health; Orange Juice
• Other Study ID Numbers: IRB202100814

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No