Dose-Response of Effera® Supplementation for Women's Health Outcomes
Led by Helaina Inc. · Updated on 2026-04-13
160
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
AI-Summary
What this Trial Is About
Researchers are evaluating whether a human equivalent lactoferrin supplement called Effera® can improve menstrual symptoms, mood, gastrointestinal symptoms, and overall quality of life in healthy women aged 18 to 40. The study compares three different doses of Effera® to a placebo to see if the supplement reduces the severity of menstrual symptoms and improves well-being.
Participants are randomly assigned to one of four groups: a placebo group, or one of three Effera® dose groups (100 mg once daily, 200 mg daily given as two 100 mg doses, or 300 mg once daily). They take their assigned supplement daily for 12 weeks. The study is conducted as a triple-blind, randomized, placebo-controlled trial with equal allocation among groups.
During the study, participants complete online questionnaires about menstrual symptoms, mood, gastrointestinal health, and quality of life at baseline and every four weeks through week 12. They also complete weekly mood assessments and optional sharing of sleep and activity data from wearable devices. Researchers monitor supplement adherence and adverse events throughout the trial. The primary outcome is change in menstrual symptoms measured at baseline and weeks 4, 8, and 12.
CONDITIONS
Brief Title
Effera Dose Response: Women's Health
Who Can Participate
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Women aged 18 to 40 years
No changes in hormonal contraception use in the past 6 months
Regular or mildly irregular menstrual cycles lasting 24 to 45 days for the past 3 months
Experience menstrual cramps with pain score of at least 4 out of 10 in most cycles over the past 6 months
Require over-the-counter pain medication for at least 2 days per period in most cycles over the past 6 months
Have at least one day per cycle where symptoms interfere with work, school, daily activities, or exercise in most cycles over the past 6 months
Notice mood or physical changes 5-7 days before menses in most cycles
Generally healthy without gastrointestinal diseases
No recent or acute infection in past 30 days and no chronic systemic illness
Stable psychiatric medication regimen for 3 or more months if used
Body mass index between 18.5 and 32.5 kg/m2
Non-smoker
Agree to avoid new vitamins or supplements during the study and not take any 24 hours before exercise test visits
Willing and able to maintain consistent diet and physical activity
Able to provide informed consent and comply with study protocol
Access to a smartphone or computer with internet for online questionnaires
Able to read and understand English at 6th-grade level
Willing to use reliable contraception or maintain sexual abstinence during the study
You will not qualify if you...
Diagnosis or treatment for Premenstrual Dysphoric Disorder or Premenstrual Syndrome
Food allergies or intolerances impacting digestion, or history of irritable bowel syndrome, inflammatory bowel disease, gastroparesis, chronic constipation or diarrhea requiring medication, or gastrointestinal surgery
Medical conditions including bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure, kidney or liver disease, diabetes, neurological diseases affecting mood or cognition, unstable thyroid disease, chronic inflammatory or immune disorders
Acute illness or infection in past 30 days
History of cancer (except localized skin cancer) within 5 years
Recent changes in certain medications including antihypertensives, hypoglycemics, asthma stimulants, or others affecting study outcomes
Habitual use of anti-inflammatory medications in 30 days prior to consent
Bipolar I/II disorder, schizophrenia spectrum or psychotic disorders, recent psychiatric hospitalization or self-harm behavior
Changes in psychotropic medications within past 3 months
Allergy to ingredients in study product
History of drug or alcohol abuse in past 12 months
Excessive alcohol use defined as more than 7 drinks per week or binge episodes
Any condition judged by the principal investigator to compromise safety or study data quality
Participation in another research study within 30 days that could affect outcomes
Currently pregnant or breastfeeding
Currently incarcerated or under state custody preventing free participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 12 weeks
Participants take their assigned supplement daily for 12 weeks. Approximately every four weeks, participants complete a series of questionnaires related to menstrual symptoms, quality of life, gastrointestinal symptoms, and other health aspects. Participants may optionally use a wearable device to track sleep and physical activity throughout the treatment.
Weekly online questionnaires and approximately 4 assessment visits during the study
A Randomized, Double-Blind, Controlled Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Immunological and Safety Parameters in Healthy Adults.
Ross D Peterson, Liana L Guarneiri, Caryn G Adams...
