Healthy
Conditions
Keywords
Pulse, Women, Skin health
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.
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
OTHERPulse 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).
OTHERControl Rice Diet
Participants will consume cooked white rice (375 calories) over 10 weeks
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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, 48 women will be enrolled in this study using a parallel design.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin sensitivity after UV radiation | 84 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| skin transepidermal water loss | 84 days | 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). |
| skin erythema and melanin index | 84 days | 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. |
| inflammation biomarkers | 84 days | * 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. |
| oxidative stress biomarkers | 84 days | Concentration of Malondialdehyde (nmol/mL) in plasma will be determined as a marker of lipid peroxidation using a photometric method. |
| skin microbiome | 84 days | For skin swabbing, a 3x3-cm square on a forearm will be swabbed with a cotton swab soaked in 0.9% sodium chloride with 0.1% Tween-20 in a Z-stroke manner |
| skin hydration | 84 days | Skin hydration (Arbitrary Units (AU) on a scale of 0-120) will be measured using a Skin Corneometer. |
| skin pH | 84 days | Skin pH will be measured using a Skin-pH-Meter. |
Countries
United States
Contacts
CONTACTLiwei Gu, PhD
CONTACTAhmad Moussa, MS
Outcome results
None listed