Healthy, Menopause
Conditions
Brief summary
The goal of this clinical trial is to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms. The main questions it aims to answer are: 1. To assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through Daily Diary and Mobile Application 2. To assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 Daily Diary and Mobile Application 3. To assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of Daily Diary, Mobile Application and validated questionnaires (GCS, MENQOL). 4. To assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (PSQI, PSS, POMS)
Interventions
DIETARY_SUPPLEMENTDietary Supplement with Proprietary Herbal Extract Blend and GABA
Eligible subjects will receive active product to take daily for seven days
OTHERPlacebo
Eligible subjects will receive Placebo to take daily for seven days
Sponsors
Olly, PBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind
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 or the brand owner or the manufactures of the product * 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 * BP ≥160/110 mmHg * Oophorectomy or amenorrhea \> two years. Note- Habitual medicine and supplement intake will be registered prior to inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Diary - 24hr | from enrollment to the end of study at seven days | To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Daily Diary. |
| Mobile App - 24hr | from enrollment to the end of study at seven days | To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Mobile Application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Dairy - Days 1-6 | from enrollment to the end of study at seven days | To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6 |
| Menopause-Specific Quality of Life (MENQOL) - Days 1-6 | from enrollment to the end of study at seven days | To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6 |
| Mobile App - Days 1-6 | from enrollment to the end of study at seven days | To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6 |
| Green Climacteric Scale (GCS) - Days 1-6 | from enrollment to the end of study at seven days | To assess changes in stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS) - Day 7 | from enrollment to the end of study at seven days | To assess changes on mood, stress and sleep scores at 7 days post treatment |
| Pittsburgh Sleep Quality Index (PSQI) - Day 7 | from enrollment to the end of study at seven days | To assess changes on mood, stress and sleep scores at 7 days post treatment |
| Profile of Mood States questionnaire (POMS) - Day 7 | from enrollment to the end of study at seven days | To assess changes on mood, stress and sleep scores at 7 days post treatment |
Countries
United States
Outcome results
None listed