Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT07524270

Effera Dose Response: Women's Health

Led by Helaina Inc. · Updated on 2026-04-13

160

Participants Needed

2

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Effera Dose Response: Women's Health

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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 (24-45 days) for the past 3 months
  • Experience menstrual cramps rated at least 4 out of 10 in most (>3) cycles over the past 6 months
  • Use over-the-counter pain medication for menstrual pain at least 2 days per cycle in most (>3) cycles over the past 6 months
  • Experience at least one day per cycle where menstrual symptoms interfere with work, school, daily activities, exercise, or cause staying home or plan changes in most (>3) cycles over the past 6 months
  • Noticeable mood or physical changes 5-7 days before menses in most cycles
  • Generally healthy with no gastrointestinal diseases or disorders affecting function
  • No recent or acute infection in the past 30 days and no chronic systemic illness
  • No psychiatric condition impairing consent, adherence, or questionnaire completion
  • If using psychiatric medication, stable regimen for 3 months with no planned changes
  • Body mass index (BMI) between 18.5 and 32.5 kg/m2 inclusive
  • Non-smoker
  • Agree to not start new vitamin, mineral, or dietary supplements during the study and avoid supplements 24 hours before exercise test visits
  • Willing and able to maintain consistent diet and physical activity habits
  • Able to provide consent and comply with study protocol
  • Access to a smartphone or computer with internet for online questionnaires
  • Able to read and understand English at a 6th-grade level
  • Willing to use reliable contraception or maintain sexual abstinence during the study
Not Eligible

You will not qualify if you...

  • Diagnosis of Premenstrual Dysphoric Disorder (PMDD) or Premenstrual Syndrome (PMS) requiring ongoing treatment
  • Food allergies or intolerances affecting 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 (≥140/90 mmHg), kidney or liver disease, diabetes type 1 or 2, neurologic diseases affecting cognition or mood, unstable thyroid disease, chronic inflammatory or immune disorders (such as HIV/AIDS), or other exclusionary conditions
  • Acute illness or infection within past 30 days
  • History of cancer (except localized skin cancer without spread) within 5 years
  • Recent start or dose change (within 90 days) of medications that may affect study outcomes, including antihypertensives, hypoglycemics, GLP1 agonists, stimulatory asthma medications, or others
  • Regular use of anti-inflammatory medications for 30 days before consent
  • Diagnosis of bipolar I/II disorder, schizophrenia, psychotic disorders; psychiatric hospitalization, suicidal ideation, attempts, or self-harm in past 12 months
  • Changes in psychotropic medication use within past 3 months
  • Allergy to any study product ingredients
  • History of drug or alcohol abuse in past 12 months
  • Excessive alcohol use (more than 7 drinks per week or binge drinking)
  • Any condition deemed unsafe or compromising study quality by the Principal Investigator
  • Participation in another research study within 30 days that could affect results
  • Currently pregnant or breastfeeding
  • Currently in prison, custody, or considered a ward of the state preventing free participation

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Alethios

San Francisco, California, United States, 94104

Actively Recruiting

2

Alethios, Inc.

San Francisco, California, United States, 94109

Not Yet Recruiting

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Research Team

C

Chad Kerksick, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

4

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