Randomized, Double-Blind, Placebo-Controlled, Parallel Study on the Effects of Effera Human Lactoferrin on Gastrointestinal Permeability
Helaina Inc.
Summary
The purpose of this study is to evaluate the impact of 28-day supplementation with effera human lactoferrin, compared to a placebo control product on indicators of gut barrier health in males and females
Description
Samples will be retained for possible analyses such lactoferrin absorption and immune biomarkers
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Male or premenopausal female, 18 - 40 years of age, inclusive 2. BMI ≥ 18.5 to \< 40.0 kg/m2 3. Abdominal adiposity defined by a waist circumference \>40" in men or \>35" in women measured at Visit 1. 4. Reports at least mild GI symptoms from the 7d GI Symptom Questionnaire collected at visit 2\. Mild GI symptoms will be defined as a combined weekly total score of gas/flatulence, abdominal distention/bloating, borborygmus/stomach rumbling, or burping symptoms ≥ 3. 5\. Non-user or former user (daily use; cessation ≥ 12 months) of tobacco or nicotine products (e.g., cig…
Interventions
- Dietary Supplementhuman lactoferrin
effera human lactoferrin
- Dietary SupplementPlacebo
Placebo Control
Location
- Biofortis IncAddison, Illinois