About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or premenopausal female, 18 - 40 years of age, inclusive
BMI ≥ 18.5 to < 40.0 kg/m2
Abdominal adiposity defined by a waist circumference >40" in men or >35" in women measured at Visit 1.
Reports at least mild GI symptoms from the 7d GI Symptom Questionnaire collected at visit
Disqualifiers
Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
Recent (≤ 3 months of visit 1) endoscopy or colonoscopy preparation.
Abnormal laboratory test results of clinical significance at visit 1, at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2, for participants with abnormal laboratory test results.
Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1. Stable use of hypertension medication is allowed (defined as no change in medication regimen within the 90 days prior to Visit 1).
Trial design
Parallel
Treatments tested in this trial
human lactoferrin
Dietary supplementeffera human lactoferrin
Placebo
Dietary supplementPlacebo Control
Treatment groups
Trial outcomes
Primary outcomes
lactulose to mannitol ratio
Change from baseline of lactulose to mannitol ratio
Secondary outcomes
Markers of gut barrier function
Change from baseline in markers of gut barrier function (such as the change in 2-8 h urine LMR from baseline to day 28, change in 7d GI Symptom Questionnaire scores from baseline to day 28, change in Digestion-associated Quality of Life Questionnaire (DQLQ) score from baseline to day 28 and change in fasting plasma LBP concentrations from baseline to day 28)
Other outcomes
Questionnaire of women's health
The change in (Menstrual Distress Questionnaire) MEDI-Q scores from baseline to day 28 in women participants experiencing a menses during the intervention
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Helaina Inc.
Lead sponsor
Biofortis Mérieux NutriSciences
Collaborator