- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06538415
Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome
April 29, 2026 updated by: University of Florida
To Determine Whether Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome and Lipids, and Reducing Oxidative Stress and Inflammation in Women
Skin health is influenced by the microbiome, lipids, oxidative stress, inflammation, and UV exposure.
A 12-week trial with 48 women aged 45-65 will test if polyphenol-rich pulses improve skin health by affecting these factors.
Using a white rice control diet, the study will measure skin parameters and analyze correlations with changes in lipids and microbiome, potentially proving the benefits of pulses.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Human skin is the largest organ in the body.
The slow deterioration of skin appearance and its barrier function are the most prominent signs of human ageing.
Cutaneous factors (microbiome and lipids) have immediate and direct impacts on skin health and functions.
Intrinsic factors (oxidative stress and inflammation) and extrinsic ones (mostly UV irritation due to sun exposure) affect the skin chronically.
Our preliminary research showed that six weeks of cranberry juice intake improved part of women's skin health parameters and decreased oxidative stress.
Its activities on the skin correlated with changes in skin microbiome and epidermal lipids.
Pulses, especially lentils and beans, are rich sources of polyphenols and fibers.
However, there is no clinical evidence on whether adding a serving of cooked mixed pulses with high polyphenol content (lentils, red kidney bean, black beans, and pinto beans) to the diet affects skin health and the underlying causes of skin aging.
Women make over 90% of the decisions on food purchases for their families.
Skin health is a major concern for women because skin aging becomes visibly noticeable after age 30.
The investigators hypothesize that polyphenol-rich pulses improve skin health by reshaping the cutaneous microbiome and lipids and suppressing inflammation and oxidative stress.
This hypothesis will be tested in a 12-week clinical trial in 50 women aged 45-65 using a randomized controlled parallel design.
The control diet will be formulated using white rice to match the calories and macronutrients of mixed pulses.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liwei Gu, PhD
- Phone Number: (352)2943730
- Email: lgu@ufl.edu
Study Contact Backup
- Name: Ahmad Moussa, MS
- Phone Number: (352) 392-0584
- Email: moussaahmad@ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- Recruiting
- Food Science and Human Nutrition
-
Contact:
- Liwei Gu, phd
- Phone Number: 352-294-3730
- Email: lgu@ufl.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- BMI (18.5-29.9)
- Body weight ≥110 pounds
- Fitzpatrick skin type 1,2 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pulse Diet
Participants will consume cooked pulses on an alternating basis over the 10-week intervention period.
The pulses consist of 455 grams of the tri-bean blend (kidney, pinto, black bean), equivalent to 350 calories, and 225 grams of black lentils (400 calories).
|
Participants will consume cooked pulses on an alternating basis over the 10-week intervention period.
The pulses consist of 455 grams of the tri-bean blend (kidney, pinto, black bean), equivalent to 350 calories, and 225 grams of black lentils (400 calories).
|
|
Active Comparator: Control Rice Diet
Participants will consume cooked white rice (375 calories) over 10 weeks
|
Participants will consume cooked white rice (375 calories) over 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin sensitivity after UV radiation
Time Frame: 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 and after 70 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).
|
84 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
skin transepidermal water loss
Time Frame: 84 days
|
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).
|
84 days
|
|
skin erythema and melanin index
Time Frame: 84 days
|
Skin erythema and melanin index ((Arbitrary Mexameter Units on a scale of 0-999) will be assessed with Mexameter.
These two components are mainly responsible for the color of the skin.
They are measured by reflectance.
|
84 days
|
|
inflammation biomarkers
Time Frame: 84 days
|
|
84 days
|
|
oxidative stress biomarkers
Time Frame: 84 days
|
Concentration of Malondialdehyde (nmol/mL) in plasma will be determined as a marker of lipid peroxidation using a photometric method.
|
84 days
|
|
skin microbiome
Time Frame: 84 days
|
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
|
84 days
|
|
skin hydration
Time Frame: 84 days
|
Skin hydration (Arbitrary Units (AU) on a scale of 0-120) will be measured using a Skin Corneometer.
|
84 days
|
|
skin pH
Time Frame: 84 days
|
Skin pH will be measured using a Skin-pH-Meter.
|
84 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 24, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
July 26, 2024
First Submitted That Met QC Criteria
August 2, 2024
First Posted (Actual)
August 5, 2024
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB202401105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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