An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause

Study Overview
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Brief Summary
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A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.

Official Title
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An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause

Conditions
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Menopause, Menopause Related Conditions, Perimenopausal Disorder

Intervention / Treatment
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* Dietary Supplement: Semaine Menopause Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day) Moderate self-reported discomfort related to perimenopause or menopause. Participants will complete the menopause well-being survey and must answer an average of moderate or higher. Exclusion Criteria: Current use of medication for high blood pressure or for blood thinning Currently undergoing chemotherapy or has previously been treated for cancer Pregnancy, breastfeeding, or attempting to become pregnant during the study Known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semaine Supplement<br>Participants are provided with a dietary supplement and are instructed to take 1 capsule per day. Participants are to take the supplement at the same time every day. If forgotten, they are to take it with the next meal. Participants will take a well-being assessment after each month (4 surveys total including the baseline.) | Dietary Supplement: Semaine Menopause Supplement<br>* Synergistic Dietary Supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause | Symptoms will be reported by the participant on a scale of perceived discomfort and will include rankings for mood, anxiety, fatigue, sleep quality, hot flashes, and libido. This survey will be based on the widely used and validated Menopause Rating Scale (MRS). The MRS will be modified to increase dynamic range by changing the response gradations from 5 to 7. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Perimenopause