Dose-Response of Effera® Supplementation for Women's Health Outcomes
Helaina Inc.
Summary
The goal of this clinical trial is to learn if a human equivalent lactoferrin supplement (effera®) can improve menstrual symptoms, mood, and quality of life in healthy women aged 18-40. The main questions it aims to answer are: Does effera® reduce the severity of menstrual symptoms? Does effera® improve mood, gastrointestinal symptoms, and overall well-being? Researchers will compare three different doses of effera® to a placebo (a look-alike supplement with no active ingredient) to see if the supplement improves these outcomes. Participants will: Take the assigned supplement (effera® or placebo) daily for 12 weeks Complete online questionnaires about menstrual symptoms, mood, and health Optionally share sleep and activity data from a wearable device
Description
Explanation of Study Design This study will be completed as a randomized, double-blind, placebo-controlled investigation with all eligible participants being randomized in an equal allocation (1:1:1:1) to each of the four study groups. Upon screening and providing consent, each study participant will complete baseline assessments and be randomized into one of four groups. Each participant will take their assigned supplement each day for 12 weeks. Approximately every four weeks participants will complete a series of questionnaires intended to evaluate menstrual symptoms, quality of life, gastro…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for participation: * Women, 18 - 40 years of age * No changes in hormonal contraception use in the past 6 months * Regular or mildly irregular cycles (24-45 days) for the past 3 months * In the majority (\>3) of menstrual cycles over the past 6 months, experience menstrual cramps on a pain scale of at least 4 out of 10 (1=no pain at all and 10 = worst pain ever experienced) * In the majority (\>3) of menstrual cycles over the past 6 months, experience pain so significant that it requires over-the-counter…
Interventions
- Dietary SupplementEffera® (human equivalent lactoferrin)
Effera® is a human equivalent lactoferrin supplement administered orally once daily at varying doses (100 mg, 200 mg, or 300 mg) depending on randomized assignment. Lactoferrin is a naturally occurring protein involved in immune regulation, iron metabolism, and inflammation.
- OtherPlacebo
Matched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks.
Locations (2)
- AlethiosSan Francisco, California
- Alethios, Inc.San Francisco, California