Health TrialsbyHealthPanel

Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI (18.5-29.9)

Body weight ≥110 pounds

Fitzpatrick skin type 1,2 and 3.

Disqualifiers

pregnancy

breast-feeding

impaired fasting glucose

frequent alcohol use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulse Diet

    Other intervention

    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).

  • Control Rice Diet

    Other intervention

    Participants will consume cooked white rice (375 calories) over 10 weeks

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Pulse DietExperimental treatment 1 intervention
Group B: Control Rice DietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Skin sensitivity after UV radiation

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).

Time frame
84 days

Secondary outcomes

1

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).

Time frame
84 days
2

skin erythema and melanin index

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.

Time frame
84 days
3

inflammation biomarkers

* Plasma concentration levels (pg/mL) of IL-6 proteins will be analyzed as inflammation biomarkers using ELISA kits. * Plasma concentration levels (mg/mL) of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits.

Time frame
84 days
4

oxidative stress biomarkers

Concentration of Malondialdehyde (nmol/mL) in plasma will be determined as a marker of lipid peroxidation using a photometric method.

Time frame
84 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov
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