Menopausal Symptoms
Conditions
Brief summary
The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.
Interventions
DIETARY_SUPPLEMENTPlacebo
Eligible subjects will receive Placebo to take daily for five weeks
DIETARY_SUPPLEMENTDietary Supplement with Proprietary Herbal Extract Blend and GABA
Eligible subjects will receive active product to take daily for five weeks
Sponsors
Olly, PBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 flushes 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 * BMI 20-40 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 subject's health under risk. * Employees of the institute * 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 * BP ≥160/110 mmHg * Oophorectomy or amenorrhea \> two years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of symptom scores in Daily Dairy | from enrollment to the end of study at five weeks | To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects |
| Changes of symptom scores in Mobile Application | from enrollment to the end of study at five weeks | To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Menopause-Specific Quality of Life (MENQOL) Scores | from enrollment to the end of study at five weeks | To assess changes in mood and quality of life scores of the product compared to placebo |
| Changes in Green Climacteric Scale (GCS) Scores | from enrollment to the end of study at five weeks | To assess changes in mood scores of the product compared to placebo |
| Changes in Perceived Stress Scale (PSS) Scores | from enrollment to the end of study at five weeks | To assess changes in mood scores of the product compared to placebo |
| Changes in Profile of Mood States (POMS) Scores | from enrollment to the end of study at five weeks | To assess changes in mood scores of the product compared to placebo |
| Changes in Pittsburgh Sleep Quality Index (PSQI) Scores | from enrollment to the end of study at five weeks | To assess changes in sleep scores of the product compared to placebo |
Countries
United States
Outcome results
None listed