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
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Food Science and Human Nutrition Department at University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04544982 -
Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin
|
N/A | |
Completed |
NCT03346447 -
Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation
|
N/A | |
Completed |
NCT05861622 -
Examining the Efficacy of a Novel Moisturizer Across Eight Weeks
|
N/A | |
Active, not recruiting |
NCT04614753 -
Dealcoholized Muscadine Wine and Skin Health in Women
|
N/A | |
Recruiting |
NCT06148740 -
An Investigation of the Effects of a Skin Serum Containing Propolis on Skin Health and Appearance
|
N/A | |
Active, not recruiting |
NCT06148766 -
An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Cream on Skin Health and Signs of Aging
|
N/A | |
Active, not recruiting |
NCT06148753 -
An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Serum on Skin Health and Signs of Aging
|
N/A | |
Completed |
NCT04511052 -
Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women
|
Phase 1/Phase 2 | |
Recruiting |
NCT05925712 -
Aerofit Post Market Investigation
|
N/A | |
Completed |
NCT02525224 -
Nutritional Supplement Efficacy on Cellular Protection and Skin Health in Generally Healthy Adults
|
N/A | |
Completed |
NCT04144777 -
Efficacy of Solarplast for Health and Oxidative Stress
|
N/A | |
Completed |
NCT03771807 -
Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
|
N/A | |
Recruiting |
NCT04183920 -
To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women
|
N/A | |
Completed |
NCT06452810 -
A Clinical Trial to Evaluate the Effects of a Skin Balm on the Appearance of the Eye Area
|
N/A | |
Completed |
NCT00864188 -
The Influence of Probiotics in a Drinkable Yogurt on Skin Health
|
Phase 1 | |
Completed |
NCT03348917 -
The Effect of Skin Cleansers on the Skin Surface Microbiome
|
Phase 4 | |
Withdrawn |
NCT03641430 -
The Effects of Over-the-Counter Products on the Skin
|
N/A | |
Recruiting |
NCT05128240 -
Nutritional Study of Fish Oil in Skin Quality in Healthy Women
|
N/A | |
Completed |
NCT00574574 -
Effects of Anthocyanin on Skin Health and Markers of Cardiovascular Disease Risk
|
N/A |