Randomized Double-Blind Study of Effera Human Lactoferrin Supplement to Improve Gut Barrier Health Compared to Placebo in Adults

What this Trial Is About

Researchers are evaluating the effects of a 28-day supplementation with effera human lactoferrin compared to a placebo on gut barrier health in both males and females aged 18 to 40 years. The study aims to understand how this dietary supplement may impact indicators of gut permeability and overall gut health. Samples collected during the study will also be used to analyze lactoferrin absorption and immune biomarkers. Participants will be randomly assigned to receive either effera human lactoferrin or a placebo supplement in a double-blind manner. The study is designed as a parallel, placebo-controlled trial with masking to reduce bias. The intervention lasts for 28 days, and the primary measurement is the lactulose to mannitol ratio, which assesses gut permeability. Secondary outcomes include various markers of gut barrier function. Throughout the study, participants will be monitored for changes in gut permeability and gut barrier markers over four weeks. They will provide diet records using a smartphone app and undergo assessments including urine sample collections. The study includes safety monitoring and requires participants to adhere to lifestyle guidelines and study procedures. Overall participation lasts about one month, during which researchers will collect data to evaluate the supplements effects.

Effects of Effera Human Lactoferrin at One Dose Compared to Placebo on Gut Permeability