Effects of 100% Orange Juice on Skin Health in Women

Skin Health Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861623
• Other study ID #: IRB202100814
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: Yavuz Yagiz, PhD
• Phone: (352) 294-3988
• Email: yavuzy[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Health

Intervention

Other:
• Orange juice
Orange juice will be purchased commercially.
• Placebo juice (Fanta)
Fanta will be purchased commercially.

Locations

Country	Name	City	State
United States	Food Science and Human Nutrition Department at University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change from baseline skin pH plus	Skin pH will be measured using a Skin-pH-Meter.	Baseline, 84 days
Primary	Change from baseline skin hydration	Skin hydration will be measured using a Skin Corneometer.	Baseline, 84 days
Primary	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
Primary	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
Primary	Change in oxidative stress	Malondialdehyde in plasma will be determined as a marker of lipid peroxidation using a photometric method.	Baseline, 84 days
Primary	Change in inflammation	Plasma levels of IL-6 proteins will be analyzed as inflammation biomarkers using ELISA kits.	Baseline, 84 days
Primary	Change in inflammation	Plasma levels of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits.	Baseline, 84 days