Food Science and Human Nutrition
Gainesville, Florida, 32608, United States
Location status: Recruiting
NCT Number: NCT06538415
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.
Interested in participating?
Request Info45 year–65 year
Female
Interventional
Not applicable
Gainesville, Florida, 32608, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Participants will consume cooked white rice (375 calories) over 10 weeks
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 84 days
Time frame: 84 days
Concentration of Malondialdehyde (nmol/mL) in plasma will be determined as a marker of lipid peroxidation using a photometric method.
Time frame: 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
Time frame: 84 days
Skin hydration (Arbitrary Units (AU) on a scale of 0-120) will be measured using a Skin Corneometer.
Time frame: 84 days
Skin pH will be measured using a Skin-pH-Meter.
Contact information is provided by the study sponsor or research team.
Ahmad Moussa, MS
CONTACT
Liwei Gu, PhD
CONTACT
University of Florida
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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