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

NCT ID: NCT06538415

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2026-12-31

Brief Summary

Skin health is influenced by the microbiome, lipids, oxidative stress, inflammation, and UV exposure. A 14-week trial with 50 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.

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 14-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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pulse Diet

Participants will consume cooked pulse (112 calories -lentils, red kidney beans, black beans, and pinto beans) during 14 weeks.

Group Type: EXPERIMENTAL

Pulse Diet

Intervention Type: OTHER

Participants will consume cooked pulse (112 calories -lentils, red kidney beans, black beans, and pinto beans) during 14 weeks.

Control Rice Diet

Participants will consume cooked rice (112 calories) during 14 weeks.

Group Type: ACTIVE_COMPARATOR

Control Rice Diet

Intervention Type: OTHER

Participants will consume cooked rice (112 calories) during 14 weeks.

Interventions

Pulse Diet

Participants will consume cooked pulse (112 calories -lentils, red kidney beans, black beans, and pinto beans) during 14 weeks.

Intervention Type: OTHER

Control Rice Diet

Participants will consume cooked rice (112 calories) during 14 weeks.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Food Science and Human Nutrition

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Liwei Gu, PhD

Role: CONTACT

lgu@ufl.edu

(352)2943730

Ahmad Moussa, MS

Role: CONTACT

moussaahmad@ufl.edu

(352) 392-0584

Facility Contacts

Liwei Gu, phd

Role: primary

lgu@ufl.edu

352-294-3730

Other Identifiers

IRB202401105

Identifier Type: -

Identifier Source: org_study_id