Viewing Study NCT06538415



Ignite Creation Date: 2024-10-25 @ 7:52 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06538415
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-26

Brief Title: Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome
Sponsor: None
Organization: None

Study Overview

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
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 womens 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None