Hormone Regulation
Conditions
Keywords
Women's Health, Menstrual Cycle, Estrogen
Brief summary
This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.
Interventions
DIETARY_SUPPLEMENTBeyond Hormone
Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles.
OTHERPlacebo
Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles.
Sponsors
Citruslabs
Scale Media Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Female at-birth, aged 25-45. * Not menopausal or perimenopausal. * Regularly menstruating. * Not taking any medication, supplement, or vitamin affecting hormone levels. * Generally healthy and not living with any uncontrolled chronic disease.
Exclusion criteria
* Medical conditions or treatments affecting hormonal regulation. * Endocrine disorders, gynecological or reproductive health conditions. * Use of hormonal contraceptives or hormone therapy. * Recent major illness or surgery. * Severe allergies or hypersensitivities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone) | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) | Measurement of hormone levels. Blood tests will be conducted to evaluate these levels at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants' Perceptions of Quality of Life | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) | Evaluation of participants' perceptions of the product's effects on quality of life with a self-reported questionnaire. |
| Participants' Mood and Energy Levels using the Visual Analog Scale (VAS) | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) | Assessment of participants' mood and energy levels using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period). |
| Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD) | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) | Evaluation of participants' monthly cycle symptoms using the Menstrual Cycle Symptom Diary (MCSD). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period). |
| Participants' Libido using a Libido Questionnaire | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) | Assessment of participants' libido using a Libido Questionnaire. These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period). |
Countries
United States
Outcome results
None listed