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

NCT06538415 | Recruiting

• 1 other identifier: IRB202401105
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Pulse; Women; Skin health

Outcome Measures

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).

  84 days

Secondary Outcomes (7)

• skin transepidermal water loss

  84 days

• skin erythema and melanin index

  84 days

• inflammation biomarkers

  84 days

• oxidative stress biomarkers

  84 days

• skin microbiome

  84 days

Study Arms (2)

Pulse Diet

EXPERIMENTAL

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).

Other: Pulse Diet

Control Rice Diet

ACTIVE COMPARATOR

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

Other: Control Rice Diet

Interventions

Pulse Diet OTHER

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).

Pulse Diet

Control Rice Diet OTHER

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

Control Rice Diet

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI (18.5-29.9)
• Body weight ≥110 pounds
• Fitzpatrick skin type 1,2 and 3.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Food Science and Human Nutrition

Gainesville, Florida, 32608, United States

RECRUITING

Central Study Contacts

Liwei Gu, PhD

CONTACT

(352)2943730; lgu@ufl.edu

Ahmad Moussa, MS

CONTACT

(352) 392-0584; moussaahmad@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial will use a randomized, controlled, parallel design. Control type I error α = 0.05 (two-tailed) and type II error β =0.2. Assume an equal number of participants in the two groups. The calculated sample size is 20 per group. Factoring in a 20% dropout rate, 48 women will be enrolled in this study using a parallel design.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 5, 2024
• Study Start: April 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-06

Locations

US (1)