Effera Dose Response: Women's Health
Dose-Response of Effera® Supplementation for Women's Health Outcomes
Helaina Inc.
160 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria20
- 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 pain medication for at least 2 days (on average) per period
- In the majority (>3) of menstrual cycles over the past 6 months, experience at least one day per cycle where menstrual symptoms either interfere with work or school performance, limit normal daily activities or exercise, or lead to staying home, leaving early, or modifying plans
- Reports noticeable mood or physical changes in the 5-7 days before menses in most cycles (irritability, mood, bloating, breast tenderness, cravings, sleep changes, etc.)
- Generally healthy and free of diseases or disorders that impact functioning of the gastrointestinal system.
- No recent or acute infection in the past 30 days and no chronic systemic illness
- No psychiatric condition that, in the investigator's judgment, would impair consent capacity, protocol adherence, or valid completion of questionnaires.
- If psychiatric medication is used: stable regimen for ≥3 months with no anticipated changes during the study
- Body mass index (BMI) 18.5 to 32.5 kg/m2 (Inclusive)
- Non-smoker
- Agrees to not use any new vitamin, mineral, or dietary supplement product until after study completion and to not take any vitamins, minerals or dietary supplements 24 hours prior to the exercise test visits.
- Willing and able to maintain consistent diet and physical activity habits
- Willing and able to provide consent and comply with the protocol
- Access to a smartphone, electronic, or personal computer with access to the internet to allow for completion of all online instruments and study reporting
- Able to read and understand English at the 6th-grade level and sign the informed consent to participate in the study
- Willing to use reliable contraception or maintain sexual abstinence during the study
Exclusion Criteria17
- Participants will be excluded if any of the following apply:
- Current or prior diagnosis from a licensed medical provider of Premenstrual Dysphoric Disorder (PMDD) or Premenstrual Syndrome (PMS) requiring ongoing medical or psychiatric treatment.
- History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel disease (Crohn's, ulcerative colitis, celiac), gastroparesis, chronic constipation or diarrhea requiring medication, or GI surgery
- Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140/90 mmHg), renal or hepatic impairment/disease, Type I or II diabetes, any neurologic disease or disorder that may impact cognition or mood, unstable thyroid disease, chronic inflammatory conditions, immune disorders (such as HIV/AIDS), or any medical condition deemed exclusionary by the Principal Investigator (PI)
- Acute illness or infection within the past 30 days
- History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- Recently started taking (within the past 90 days or has had their dosage adjusted in the past 90 days) antihypertensives, hypoglycemic medications, GLP1 agonists of any class or type, stimulatory asthma medications, or any other prescription or over-the-counter medication that confound the outcomes measured in this study
- Habitual use of anti-inflammatory medications for 30 days prior to providing consent
- Current or past diagnosis of bipolar I/II disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, attempt, or self-harm behavior in the past 12 months
- Initiation, discontinuation, or dose change of any psychotropic medication within the past 3 months, including antidepressants, anxiolytics, antipsychotics, mood stabilizers, stimulants, or sedative-hypnotics
- Subject has an allergy to any ingredients in the study product
- Subject has a history of drug or alcohol abuse in the past 12 months
- Excessive alcohol intake defined as greater than 7 drinks/week or binge episodes
- Any condition or abnormality that in the expert opinion of the PI, participation in the study would compromise the safety of the subject or the quality of the study data.
- Participating in or has participated in another research study within 30 days prior to the screening visit that could confound outcomes
- Currently pregnant or lactating
- Currently in prison, custody, or otherwise considered a ward of the state preventing their ability to free participate
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Interventions
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.
Matched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07524270