Skin HealthNCT04861623
Effects of 100% Orange Juice on Skin Health in Women
A study testing Orange juice in people with Skin Health, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Orange juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI (18.5-29.9)
- Body weight ≥110 pounds
- Fitzpatrick skin type 2 and 3.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Science and Human Nutrition Department at University of Florida
Gainesville, Florida, 32611
About this study
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.
Read the 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 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
- Skin Health
- Being tested
- Orange juice, Placebo juice (SunnyD)
- Keywords
- Orange Juice, Skin health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceOther
Orange juice will be purchased commercially.
Placebo juice (SunnyD)Other
SunnyD beverage will be purchased commercially.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Orange juice; Other: 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. Receives: Other: Orange juice; Other: Placebo juice (SunnyD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 84 days
Secondary outcomes (7)
Skin transepidermal water loss
Skin transepidermal water loss will be measured using a Tewameter to evaluate the water barrier function of the skin.
Measured: Baseline, 84 days
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.
Measured: Baseline, 84 days
Inflammation biomarkers
Plasma levels of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits.
Measured: Baseline, 84 days
Inflammation biomarkers
Plasma levels of IL-6 proteins will be analyzed as inflammation biomarkers using ELISA kits.
Measured: Baseline, 84 days
oxidative stress
Malondialdehyde in plasma will be determined as a marker of lipid peroxidation using a photometric method.
Measured: Baseline, 84 days
skin hydration
Skin hydration will be measured using a Skin Corneometer.
Measured: Baseline, 84 days
skin pH
Skin pH will be measured using a Skin-pH-Meter.
Measured: Baseline, 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start4 Jan 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861623
- Sponsor's protocol ID
- IRB202100814
- Status last verified
- Mar 2025
- First submitted
- 20 Apr 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28112913Heinrich 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.
PubMed 21525260Heinrich 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.
PubMed 16702322Heckman 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.
PubMed 23748556Manippa 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.
PubMed 29270120
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04861623
- Acronym / sponsor ID
- IRB202100814
- Conditions
- Skin Health
- Keywords
- Orange Juice, Skin health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange Juice then Placebo juice (SunnyD) | Active comparator | Other: Orange juice, Other: 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. |
| Placebo (SunnyD) then Orange juice | Active comparator | Other: Orange juice, Other: Placebo juice (SunnyD)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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI (18.5-29.9)
- Body weight ≥110 pounds
- Fitzpatrick skin type 2 and 3.
Key exclusion criteria (8 listed)
- pregnancy
- breast-feeding
- impaired fasting glucose
- frequent alcohol use
- history of skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juiceOrange juice will be purchased commercially. | Other | Orange Juice then Placebo juice (SunnyD), Placebo (SunnyD) then Orange juice |
| Placebo juice (SunnyD)SunnyD beverage will be purchased commercially. | Other | Orange Juice then Placebo juice (SunnyD), Placebo (SunnyD) then Orange juice |
Primary outcome
Skin UV sensitivity
Time frame: Baseline, 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. The a*-value (red/green-axis) is a measure of reddening (erythema).
7 secondary outcomes
Skin transepidermal water loss
Time frame: Baseline, 84 days
Skin erythema and melanin index
Time frame: Baseline, 84 days
Inflammation biomarkers
Time frame: Baseline, 84 days
Inflammation biomarkers
Time frame: Baseline, 84 days
oxidative stress
Time frame: Baseline, 84 days
skin hydration
Time frame: Baseline, 84 days
skin pH
Time frame: Baseline, 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 28112913Li 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.
- Background: PubMed 21525260Heinrich 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.
- Background: PubMed 16702322Heinrich 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.
- Background: PubMed 23748556Heckman 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.
- Background: PubMed 29270120Manippa 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.
Related trials for Skin Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Enrolling by invitationPhase 2
Deployment and Evaluation of Humanoid Robotics in Coalition-Aligned Clinical Care Settings
Mobility Impairment, Clinical Workflow Optimization
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
RecruitingObservational study
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice in people with Skin Health, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin UV sensitivity (time frame: Baseline, 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04861623, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.