The MenoLabs Difference
MenoLabs clinical research shows efficacy of health app data collection and probiotic supplements for menopause symptoms.
MenoLabs Customers Report*:
- Up to 92% reduction in hot flashes
- Up to 80% reduction in mood swings
- Up to 71% improved mood
- Up to 67% fewer headaches
- Up to 67% reduction in cramps
- Up to 64% reduction in allergies
- Up to 64% reduction in anxiety
- Up to 46% reduction in insomnia
- A higher percentage of body weight lost**
- A lower percentage of body weight gained**
Why we run our own research studies
By 2025, one billion women will have experienced menopause. This transition can be life-disrupting, lasting from 4 to 14 years, with 33 or more symptoms. Women in the United States spend billions on hormone replacement therapy and other treatments with known risks to alleviate these symptoms. Additionally, the result of the menopausal transition is one that has a significant impact on the health and lives of women.
Even though a majority of US citizens will experience this transition, and it is one of the major health and well-being impacts in a woman’s life, the institutional funding mechanisms for research into this transition and how to support better health outcomes for women remain dramatically below the levels of many other health concerns.
Our efforts are to use Real World Evidence (RWE) to document symptoms, symptom triggers, and overall health and well-being inputs that may impact women and capture the impact of natural support supplements on these symptoms, using far larger sample sizes than traditional clinical studies.
By increasing our study population size and consistently adding more depth to symptom, health, and behavioral tracking we can inform strategies and behaviors for women to consider that suggest better quality of life outcomes in the immediate term, and improved transition through menopause.
By combining this overall research with specific retrospective analysis of MenoLabs natural formulas to support the menopausal transition, we can gather significant, robust data as to the efficacy of these natural supplements’ impacts on menopausal symptoms.
As industry and research leaders have discovered, RWE that is recorded contemporaneously outside of the confines of formal studies reveals novel statistical connections and effectively captures surprising relationships in behavior and outcomes that can better inform traditional formal studies. By leveraging current technology we can build robust data sets and complex models that reveal particular patterns, so that the limited research funding which is allocated to women’s midlife health can be most efficiently applied to yield better understanding of this transition and its impact on women’s health.
How we recruited participants and collected data
Recruitment of participants consisted of an advertisement to the target population of women, ages 35-75, recruited from Facebook, the MenoLabs website, and existing beta-testers of MenoLife, the smartphone app built by MenoLabs. Over 500,000 participants completed responses to our menopause quiz. Quiz results were screened for participants who met the target age group and invited to download the app and be on-boarded to use the app.
All data extracted from participants was de-identified and assigned a unique user identification prior to entry into the study database. Participants were stratified into 2 groups: (1) Product Takers (PT) and (2) Product non-Takers (PnT).
A total of 6,694 users recorded 60,133 symptoms. The split between PT and PnT for users was 27% & 73%, while the split for symptoms was 74% & 26% respectively.
Data was collected over the period between October 1st, 2020 through June 29th, 2021 for a total of 271 days. Of the 15,703 total app users, 3,982 (25%) were PT and 11,721 (75%) were PnT. We stratified participants based on whether at least 1 of 45 symptoms was reported using the app for greater than 30 days.
Symptoms in the MenoLife app were chosen after careful curation from menopause focus groups and existing literature [Pimenta et al. (2012); Chedraui et al. (2007); Ahsan et al. (2015); Heinemann et al. (2004)]. Figure 2 shows the total number of participants who entered at least 1 symptom was 6,694 (43% of user base) with 1,802 (27%) PT and 4,892 (73%) PnT. Every symptom app entry was identified as a single reported event. Total number of reported symptom events was 60,133 resulting in 222 reported events/day. Of the total number of reported symptom events, 15,647 (26%) were reported from PT and 44,486 (74%) were reported from PnT as shown in Figure 2. In general, symptom reporting number and frequency paralleled overall distribution of PT and PnT participants, suggesting similar reporting behaviors.
What participants reported about their weight loss/weight gain
Participants were prompted to enter a weight value during each check-in. Sixty percent (5,791) of participants recorded weight entries: 1,818 PT and 3,973 PnT. The percent total reported instances due to a weight check-in was 37% (15,220), collectively from 6,620 PT and 8,600 PnT check-ins. In order to reduce the confounding impact of day-to-day weight fluctuations typically experienced by a menopausal population, we further curated the participant cohort to those who demonstrated long-term compliance by reporting weight for 10 weeks or more. This step resulted in a final participant population of 1,246 PT (29% of the total PT) and 882 PnT (31%).
On average, PT participants lost significantly more weight than the PnT cohort as shown in Figure 5; alternatively, PT who reported an increase in weight, reported an amount of weight gained that was significantly less compared to PnT who gained weight. PT participants lost an average of 4.12% (σ=0.15) of their body weight over the course of 10 weeks, while the PnT participants lost an average of 3.6% (σ=0.08) of their body weight. As for weight gain, PT participants reported an average gain of 3.15% of their body weight (σ=0.14) as compared to PnT, which reported a higher average weight gain of 5.1% (σ=0.4) of their body weight. To better represent the amount of weight loss differences between PT and PnT participants, the percentage of PT or PnT participants that lost a specific amount of weight is illustrated in Figure 6. The percentage of PT participants that reported a 6-7% decrease in weight was 27% of the participant population, compared to 9% of the PnT cohorts who lost weight. Further, the same 9% of the PnT participants reported a decrease in body weight of at least 8% body weight compared to 19% of the PT participants. Finally, no PnT participants reported weight loss that was greater than 9%, whereas 19% of PT participants lost at least 9%, with 10% of the PT population reporting at least 10% of weight loss.
In summary, we establish feasibility of MenoLife to capture RWD as evidenced by the accumulation of self-reported metrics from 15,703 users, who reported 58,636 symptoms and 53,589 check-ins. We further demonstrate efficacy of a nutritional, synbiotic intervention to alleviate menopausal conditions from RWE. There was a statistically significant reduction in symptoms reporting when comparing Product Takers (PT) to Product non-Takers (PnT) for the most highly reported menopausal symptoms. Salient findings also include a reduction in daily reports of hot flashes (92% in 85% of PT participants), headaches (67% in 65% of PT participants) and mood swings (80% reduction in 70% of PT participants). We also observed a reduction in weekly reports of insomnia by 46% in 85% of PT participants and night sweats by 25% in 80% of PT participants. Consistent with the initiation of a gut-based intervention (synbiotic), 95% of the PT population reported a 17% increase in bloating. We further addressed the overall impact of MenoLabs synbiotics on mood and weight through a unique check-in prompt. We introduce the metric of Mood Boost as a method to quantitatively assess the subjective feeling of mood. Using this measure, PT reported a 71% increase in Mood Boost. Over a 10 week window of user-reported weight data, 27% of PT experienced a 6-7% decrease in body weight, with only 9% of the PnT cohort experiencing the same results. Importantly, only PT participants reported weight loss over 9%. Finally, we contend that MenoLife facilitates rapid and robust collection of RWD with significant granularity and a platform for scalability, providing the critical foundation for precision approaches in a long ignored menopausal population.
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MenoLabs Clinical Research Shows Efficacy of Health App Data Collection and Probiotic Supplements for Menopause Symptoms
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