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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • human lactoferrin

    Dietary supplement

    effera human lactoferrin

  • Placebo

    Dietary supplement

    Placebo Control

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Dietary supplement: effera human lactoferrinExperimental treatment 1 intervention
Group B: Dietary Supplement: Placebo ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

lactulose to mannitol ratio

Change from baseline of lactulose to mannitol ratio

Time frame
0, 4 weeks

Secondary outcomes

1

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)

Time frame
0, 4 weeks

Other outcomes

1

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

Time frame
0, 4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helaina Inc.

Lead sponsor

Biofortis Mérieux NutriSciences

Collaborator