MenopauseNCT06148714
A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause
A study testing Provitalize Natural Menopause Probiotic in people with Menopause, run by Maneuver Marketing at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Provitalize Natural Menopause Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Menopause
- Being tested
- Provitalize Natural Menopause Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provitalize Natural Menopause ProbioticDietary supplement
Supplement containing a Probiotic blend of Bifidobacterium breve, Lactobacillus Gasseri, and Bifidobacterium animalis subsp. Lactis.
PlaceboOther
Placebo comparator containing Pure hydroxypropyl methylcellulose (HPmC) with food dye.
| Study group | Role | What they receive |
|---|---|---|
| Provitalize Probiotic | Experimental | Participants will take 2 capsules every morning on an empty stomach before their first meal of the day. Receives: Dietary Supplement: Provitalize Natural Menopause Probiotic |
| Placebo | Placebo comparator | Participants will take 2 capsules every morning on an empty stomach before their first meal of the day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight. [Timeframe: Baseline to Day 90]
Participants will weigh themselves using a Fitbit Smart Scale that they will be provided with.
Measured: 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.
Measured: 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.
Measured: 90 days
Secondary outcomes (11)
Changes in the frequency of hot flashes. [Timeframe: Baseline to Day 90]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 90 days
Changes in the frequency of night sweats. [Timeframe: Baseline to Day 90]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 90 days
Changes in the severity of brain fog experienced. [Timeframe: Baseline to Day 90]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 90 days
Changes in the severity of mood swings. [Timeframe: Baseline to Day 90]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 90 days
Changes in the severity of fatigue. [Timeframe: Baseline to Day 90]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 90 days
Changes in the severity of bloating. [Timeframe: Baseline to Day 90]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 90 days
Changes in the frequency of bloating. [Timeframe: Baseline to Day 90]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 90 days
Changes in the severity of joint pain. [Timeframe: Baseline to Day 90]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 90 days
Changes in total time asleep. [Timeframe: Baseline to Day 90]
Measured using Fitbit wearable sleep tracker.
Measured: 90 days
Changes in overall sleep score provided by Fitbit wearable sleep tracker. [Timeframe: Baseline to Day 90]
The sleep score is based on heart rate, the time spent awake or restless, and sleep stages. The score is given out of 100, with 100 indicating the best possible score.
Measured: 90 days
Changes in total time awake at night. [Timeframe: Baseline to Day 90]
Measured using Fitbit wearable sleep tracker.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maneuver Marketing
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148714
- Sponsor's protocol ID
- 20379
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause
- ClinicalTrials.gov ID
- NCT06148714
- Acronym / sponsor ID
- 20379
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maneuver MarketingIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Provitalize Probiotic | Experimental | Dietary Supplement: Provitalize Natural Menopause ProbioticParticipants will take 2 capsules every morning on an empty stomach before their first meal of the day. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will take 2 capsules every morning on an empty stomach before their first meal of the day. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provitalize Natural Menopause ProbioticSupplement containing a Probiotic blend of Bifidobacterium breve, Lactobacillus Gasseri, and Bifidobacterium animalis subsp. Lactis. | Dietary supplement | Provitalize Probiotic |
| PlaceboPlacebo comparator containing Pure hydroxypropyl methylcellulose (HPmC) with food dye. | Other | Placebo |
Primary outcome
Change in body weight. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Participants will weigh themselves using a Fitbit Smart Scale that they will be provided with.
Change in waist circumference. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Participants will measure their waist circumference using a tape measure that they will be provided with.
Changes in scores on the Bristol Stool Chart. [Timeframe: Baseline to Day 90]
Time frame: 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.
11 secondary outcomes
Changes in the frequency of hot flashes. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in the frequency of night sweats. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in the severity of brain fog experienced. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in the severity of mood swings. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in the severity of fatigue. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in the severity of bloating. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in the frequency of bloating. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in the severity of joint pain. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in total time asleep. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in overall sleep score provided by Fitbit wearable sleep tracker. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Changes in total time awake at night. [Timeframe: Baseline to Day 90]
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provitalize Natural Menopause Probiotic in people with Menopause, run by Maneuver Marketing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight. [Timeframe: Baseline to Day 90] (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.