Effera Dose Response: Women's Health

Helaina Inc.160 enrolled

Overview

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

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, gastrointestinal symptoms, health, and more specific menstrual symptoms specifically aligned around their menstrual cycle. Participants are allowed to stop their participation or withdraw at any time. Supplementation Groups Placebo Effera300 (1 daily dose of 300 mg) Effera100 (1 daily dose of 100 mg) Effera2x100 (2 daily doses of 200 mg) Participants will be randomized to one of the four arms of the study using simple randomization (ABAB) and an even allocation ratio (1:1:1:1). Order of Study Procedures (See Study Table Below) Week 0 (Day -28 to Day -3): Informed consent process Eligibility determination via review of inclusion/exclusion criteria and medical/health history review Review medications Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Complete menstrual complications symptoms questionnaire during first seven days of their next cycle Optional (If available): Sync their compatible wearable device to upload sleep and physical activity data Take first dose Report any adverse events Weeks 1-3 Complete Patient Health Questionnaire (PHQ-4) each week Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events Week 4 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events Weeks 5-7 Complete Patient Health Questionnaire (PHQ-4) each week Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events Week 8 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events Weeks 9-11 Complete Patient Health Questionnaire (PHQ-4) each week Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events Week 12 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data through completion of final assessments Continue taking assigned supplement through completion of final assessments Study Table Action (Weeks) Information (0) Demographics (0) Inclusion/Exclusion Review (0) Medical/health history review (0) Medication Review (0) Menstrual Symptoms Questionnaire-24 (MSQ-24) (0, 4, 8, 12) PROMIS Global Health (0, 4, 8, 12) Patient Health (PHQ-4) (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) PROMIS-GI Combined Short Form (0, 4, 8, 12) Menstrual Cycle Comfort Questionnaire (Days before mensense, 0, 4, 8, 12) Optional: Sleep \& Physical Activity Tracker (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) Supplement Compliance (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) Adverse Event Reporting (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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 Criteria: 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

Outcomes

Primary Outcomes

Change in menstrual symptoms (MSQ-24 score)

Menstrual symptoms will be assessed using the validated 24-item Menstrual Symptoms Questionnaire (MSQ-24), which measures the severity and frequency of physical, emotional, and behavioral symptoms associated with the menstrual cycle. Each item will be presented as a 5-level Likert scale (1=Never; 2=Rarely; 3=Sometimes; 4=Often; 5=Always). Higher scores indicate greater symptom burden.

Time frame: Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes

Change in global health (PROMIS Global Health-10)

Assesses overall physical and mental health, including quality of life, fatigue, pain, and emotional well-being. This assessment has ten separate items. Nine items are scored on a 5-point scale ranging from 1 to 5 while the remaining item is scored on a scale that ranges from 0 (No Pain to 10 (Worst imaginable pain). The ten items are broken up into a physical health scale and a mental health scale. Each question can be converted to a T-score whereby higher scores indicate better physical or mental health, while pain and fatigue are reverse scored (lower score is better).

Time frame: Baseline, Week 4, Week 8, and Week 12

Change in psychological distress (PHQ-4)

A brief, validated 4-item questionnaire measuring symptoms of anxiety and depression. It consists of four items and provides a general indicator of psychological distress over the previous two weeks. Each item is scored on a 4-item scale (0=Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day) resulting in a possible total score of 0-12 with higher scores indicating more severe feelings of anxiety or depression.

Time frame: Weekly from Baseline through Week 12

Change in gastrointestinal symptoms (PROMIS-GI Short Form)

Assesses frequency and severity of gastrointestinal symptoms such as bloating, abdominal pain, and nausea. This questionnaire has 15 items that are scored between 1 (No discomfort at all) to 7 (Very severe discomfort). Scores are summed across the questionnaire with possible scores ranging from 15 - 105. A higher score indicates more discomfort.

Time frame: Baseline, Week 4, Week 8, and Week 12

Change in menstrual cycle-specific symptoms

Assessed using a menstrual cycle-specific symptom questionnaire completed during the first few days of the most menstrual cycle to evaluate acute symptom changes. The assessment consists of 12 items that are scored on a 3-item scale (0=Not at all; 1=Mild; 2=Moderate; 3=Severe) resulting in total scores that range from 0 to 36.

Time frame: Baseline and monthly during the study (Weeks 4, 8, and 12)

Effera Dose Response: Women's Health

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts