Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulse Diet, Control Rice Diet.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 45 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- Other 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). - Other Control Rice Diet
Participants will consume cooked white rice (375 calories) over 10 weeks
Primary outcome measures
- Skin sensitivity after UV radiation [Time frame: 84 days]
Secondary outcome measures (7)
- skin transepidermal water loss [Time frame: 84 days]
- skin erythema and melanin index [Time frame: 84 days]
- inflammation biomarkers [Time frame: 84 days]
- oxidative stress biomarkers [Time frame: 84 days]
- skin microbiome [Time frame: 84 days]
- skin hydration [Time frame: 84 days]
- skin pH [Time frame: 84 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Food Science and Human Nutrition — Gainesville
Identifiers
NCT: NCT06538415 · IRB202401105