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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorHelaina Inc.

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

Qualifiers

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

Treatments tested in this trial

  • human lactoferrin
  • Placebo

Treatment groups

46 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Helaina Inc.

Lead sponsor

Biofortis Mérieux NutriSciences

Collaborator