A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in waist circumference. [Timeframe: Baseline to Day 90]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study will be triple-blinded in that the study participants, the study coordinators, and the data analysis team will be blinded to the intervention or product allocation. Only the sponsor will know which product contains the active ingredients. After the study analysis is complete, the allocation will be unblinded.
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Provitalize Probiotic
Participants will take 2 capsules every morning on an empty stomach before their first meal of the day.
干预措施: Provitalize Natural Menopause Probiotic (Dietary Supplement)
Placebo
Participants will take 2 capsules every morning on an empty stomach before their first meal of the day.
干预措施: Placebo (Other)
结局指标
主要结局
Change in waist circumference. [Timeframe: Baseline to Day 90]
时间窗: 90 days
Participants will measure their waist circumference using a tape measure that they will be provided with.
Change in body weight. [Timeframe: Baseline to Day 90]
时间窗: 90 days
Participants will weigh themselves using a Fitbit Smart Scale that they will be provided with.
Changes in scores on the Bristol Stool Chart. [Timeframe: Baseline to Day 90]
时间窗: 90 days
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.
次要结局
- Changes in the frequency of hot flashes. [Timeframe: Baseline to Day 90](90 days)
- Changes in the frequency of night sweats. [Timeframe: Baseline to Day 90](90 days)
- Changes in the severity of mood swings. [Timeframe: Baseline to Day 90](90 days)
- Changes in the severity of fatigue. [Timeframe: Baseline to Day 90](90 days)
- Changes in the severity of bloating. [Timeframe: Baseline to Day 90](90 days)
- Changes in the severity of joint pain. [Timeframe: Baseline to Day 90](90 days)
- Changes in total time asleep. [Timeframe: Baseline to Day 90](90 days)
- Changes in overall sleep score provided by Fitbit wearable sleep tracker. [Timeframe: Baseline to Day 90](90 days)
- Changes in total time awake at night. [Timeframe: Baseline to Day 90](90 days)
- Changes in the severity of brain fog experienced. [Timeframe: Baseline to Day 90](90 days)
- Changes in the frequency of bloating. [Timeframe: Baseline to Day 90](90 days)