A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause

Maneuver Marketing100 enrolled

Overview

Symptoms of menopause can significantly affect overall quality of life. It is hypothesized that probiotic supplements can reduce the severity of these symptoms. This 90-day randomized controlled trial will examine the effects of the Provitalize Natural Menopause Probiotic on weight loss, waist circumference, sleep, and symptoms of menopause including hot flashes, night sweats, mood swings, anxiety, fatigue and brain fog. Participants will take either the test product or a placebo daily. All participants will complete study-specific questionnaires and provide sleep data from their Fitbit at Baseline, Day 30, Day 60 and Day 90. At Baseline, Day 30, Day 60 and and Day 90, participants will also provide a bodyweight measurement and a waist circumference measurement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

100

Conditions

Menopause

Interventions

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 45-65 years old * Must experience hot flashes and/or night sweats at least once per day * Must also be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes * Can be either natural or surgical menopause * Has not had a period in the last 12 consecutive months * Willing to adhere to the study protocol for the duration of the study * Willing to stop taking any other herbal remedies or supplements for the duration of the study * Self-reports as "generally healthy" * Has never taken Provitalize before * No planned invasive medical procedures for the duration of the study or in the three weeks leading up to the study start Exclusion Criteria: * Not experiencing hot flashes and/or night sweats at least once per day and two other symptoms of menopause such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes * Unwilling to stop taking any other herbal remedies or supplements for the duration of the study * Current use of conventional hormone replacement therapies, or plan to start during the study duration * Current use of hormonal birth control, or plan to start during the study duration * Known allergies or hypersensitivities to any product ingredients * Current or history of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear * Anyone with any known severe allergies requiring the use of an epi-pen * Unwilling to adhere to the study protocol * Anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders * Pregnant, breastfeeding or trying to conceive * Currently taking a prescription sleep aid

Outcomes

Primary Outcomes

Change in body weight. [Timeframe: Baseline to Day 90]

Participants will weigh themselves using a Fitbit Smart Scale that they will be provided with.

Time frame: 90 days

Change in waist circumference. [Timeframe: Baseline to Day 90]

Participants will measure their waist circumference using a tape measure that they will be provided with.

Time frame: 90 days

Changes in scores on the Bristol Stool Chart. [Timeframe: Baseline to Day 90]

The Bristol Stool Chart is widely used as a research tool to evaluate the effectiveness of treatments for various diseases of the bowel. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.

Time frame: 90 days