Healthy
Conditions
Brief summary
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo
DIETARY_SUPPLEMENTDietary Supplement with actives
Dietary supplement containing EstroG-100 and GABA
Sponsors
Olly, PBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Females aged 40 to 65 years * Self-reporting menopausal symptoms (\> 5 hot flashes per day) and have been present for a minimum of previous 60 days prior to baseline visit * Reporting a variable cycle length of \> 7 days different from normal * NORMAL BMI (per metropolitan life tables): under 30 kg/m2 * Able to read, understand, and complete the study questionnaire and records. * Able to understand the study procedures. * Able to comply with all study requirements. * Written informed consent to participate in the study. * Willingness to actively participate in the study and to come to the scheduled visits.
Exclusion criteria
* Pregnancy or breastfeeding. * Immune insufficiency * Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal. * History of hysterectomy * Women on hormone replacement therapy * Use of systemic corticosteroids or immunosuppressant drugs. * Other diseases or medications that might directly interfere in the study or put the panelist's health under risk, such as: thyroid disease, diabetes mellitus, history of hormone dependent (gynecological) cancer, endometrial hyperplasia, uterine cancer, endometrial cancer, drug and alcohol abuse, mental disorder, abnormality in renal and liver functions, personal or family history of breast cancer in a first degree relative, and history of clotting disorder such as deep vein thrombosis.) * Cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol * Alcohol or drug abuse * Use of hormonal contraceptives within the last 3 months * Use of other menopause supplements or drugs * Uncontrolled hypertension (160/100 mmHg or higher, measured after 10 min of seated rest) * Oophorectomy or amenorrhea \> two years. * Participating in a different clinical trial within one month of the start of this clinical trial or planning to participate in another clinical trial during the trial period * Continuous intake of foods based on Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai within the past month * Employees of the institute or the brand owner or the manufacturers of the product * Note: Habitual medicine and supplement intake will be registered prior to inclusion in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour effects following single dose of Mellow Menopause - Hot Flashes | From baseline Day 7 to Treatement Day 1 (Day 8 of study) | To assess the efficacy for improvement of a treatment product on menopausal vasomotor symptoms (hot flashes- intensity, duration) within 24 hours compared to placebo through daily diary data and MenoLife application based diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of overall daily menopausal vasomotor symptoms | from enrollment to end of study at Day 15 | To assess the efficacy for improvement of overall daily menopausal vasomotor symptoms compared to placebo through daily diary data and MenoLife diary though 7 days. Data in the Daily diary and MenoLife Diary will be compared between the active supplement and placebo groups across different time points. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess Menopause symptoms using the Greene Climacteric Scale (GCS). | from enrollment to end of study at Day 15 | To assess the efficacy of the investigation product on menopause symptoms using a validated questionnaire Greene Climacteric Scale (GCS). Data from the GCS Score will be compared between the active supplement and placebo groups across different time points. |
Countries
United States
Outcome results
None listed