Clinical trial NCT06538415: Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Pulse
Women
Skin health
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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, 50 women will be enrolled in this study using a parallel design.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Skin sensitivity after UV radiation
timeFrame: 100 days
Secondary outcomes:
measure: skin transepidermal water loss
timeFrame: 100 days
measure: skin erythema and melanin index
timeFrame: 100 days
measure: inflammation biomarkers
timeFrame: 100 days
measure: oxidative stress biomarkers
timeFrame: 100 days
measure: skin microbiome
timeFrame: 100 days
measure: skin hydration
timeFrame: 100 days
measure: skin pH
timeFrame: 100 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Food Science and Human Nutrition
state: Florida
Study officials:
References: