MenopauseNCT06018740
A Study to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause
A study testing Daily Balance Gummy in people with Menopause and Perimenopause, run by Hologram Sciences at 1 site in United States.
Trial summary
Symptoms of perimenopause and menopause can significantly affect overall quality of life. It is hypothesized that daily supplements can reduce the severity of these symptoms. This 12-week clinical trial will examine the effects of Hologram Sciences' Daily Balance Gummy Supplements on symptoms including hot flashes… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Perimenopause
- What is being tested?
- Daily Balance Gummy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 13 Nov 2023
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 40-65 years old Must 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, irregular or absent periods, or vaginal changes Must experience hot flashes and/or night sweats at least 5 times per day Can be either natural or surgical menopause (or perimenopause) Willing to adhere to the study protocol for the duration of the study
- Willing to consult with their physician prior to starting the trial if taking any of the following medications:
- Levothyroxine Liothyronine Calcipotriene (Dovonex) Digoxin (Lanoxin) Diltiazem (Cardizem) Verapamil (Calan, others) Thiazide diuretics Atorvastatin (Lipitor) Warfarin - Might increase the amount of time it takes for blood clotting. Minosalicylic acid (Paser) Colchicine (Colcrys, Mitigare, Gloperba) Metformin (Glumetza, Fortamet, others) Proton pump inhibitors (omeprazole (Prilosec), lansoprazole (Prevacid) or other stomach acid-reducing drugs) Phenytoin (Dilantin) Antihypertensive drugs Phenobarbital (Luminal) Amiodarone (Cordarone) Levodopa
Who cannot join
- Not experiencing hot flashes and/or night sweats at least 5 times per day Has taken herbal supplements or multivitamins within the last 1 month 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 to any product ingredients including the purified isoflavone genistein 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 No planned invasive medical procedures for the duration of the study Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Group Clinical Trial to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause
Symptoms of perimenopause and menopause can significantly affect overall quality of life. It is hypothesized that daily supplements can reduce the severity of these symptoms. This 12-week clinical trial will examine the effects of Hologram Sciences' Daily Balance Gummy Supplements on symptoms including hot flashes, night sweats, mood swings, anxiety, fatigue, and brain fog. Participants will take the product daily and complete study-specific questionnaires at Baseline, Week 4, Week 8, and Week 12. Upon conclusion of Week 12, participants will be asked to count how many gummies remain in their jar.
- Conditions
- Menopause, Perimenopause
- Being tested
- Daily Balance Gummy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Balance GummyDietary supplement
Phenology Daily Balance Gummies 30 ct. Yuzu Tangerine Flavor. Product contains Vitamin D2, Vitamin K2, Vitamin B6, Vitamin B12, Biotin, Genistein, Saffron Extract, Organic Tapioca Syrup, Organic Cane Sugar, Water, Pectin, Citric Acid, Natural Flavors.
| Study group | Role | What they receive |
|---|---|---|
| Daily Balance Gummy | Experimental | One Daily Balance Gummy should be taken with the last meal of the day. Receives: Dietary Supplement: Daily Balance Gummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in score on the Menopause Rating Scale (MRS). [Baseline to Week 12]
The Menopause Rating Scale (MRS) is a commonly used assessment tool in medical and research settings to evaluate the severity and impact of menopausal symptoms on women's lives. 5 point Likert scale, with the following points relating to menopausal symptoms: 0 - None (absent)
- - Mild (light)
- - Moderate (medium)
- - Severe (heavy)
- - Very severe (very heavy)
Measured: 12 weeks
Change in hot flashes. [Baseline to Week 12]
Survey-based assessment (0-5 point scale) of changes in hot flashes. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('Extremely often') and 5 representing the most beneficial response (i.e., "never").
Measured: 12 weeks
Change in night sweats. [Baseline to 12 Weeks]
Survey-based assessment (0-5 point scale) of changes in night sweats. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Measured: 12 weeks
Change in brain fog. [Baseline to Week 12]
Survey-based assessment (0-5 point scale) of changes in brain fog. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Measured: 12 weeks
Change in mood swings. [Baseline to Week 12]
Survey-based assessment (0-5 point scale) of changes in mood swings. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Measured: 12 weeks
Change in sleep disturbances. [Baseline to Week 12]
Survey-based assessment (0-5 point scale) of changes in sleep disturbances. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Measured: 12 weeks
Change in fatigue. [Baseline to Week 12]
Survey-based assessment (0-5 point scale) of changes in fatigue. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Measured: 12 weeks
Secondary outcomes (1)
Changes in participant-reported quality of life. [Baseline to Week 12]
Survey-based assessment (0-5 point scale) of quality of life. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('Very Poor') and 5 represents the most beneficial response (i.e., "Excellent").
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start14 Aug 2023
- Primary completion6 Nov 2023
- Study completion13 Nov 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group clinical trial.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologram Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018740
- Sponsor's protocol ID
- 20356
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2023
- Last updated
- 29 Feb 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Clinical Trial to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause
- ClinicalTrials.gov ID
- NCT06018740
- Acronym / sponsor ID
- 20356
- Conditions
- Menopause, Perimenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hologram SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 31 Aug 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 perimenopause and menopause can significantly affect overall quality of life. It is hypothesized that daily supplements can reduce the severity of these symptoms. This 12-week clinical trial will examine the effects of Hologram Sciences' Daily Balance Gummy Supplements on symptoms including hot flashes, night sweats, mood swings, anxiety, fatigue, and brain fog. Participants will take the product daily and complete study-specific questionnaires at Baseline, Week 4, Week 8, and Week 12. Upon conclusion of Week 12, participants will be asked to count how many gummies remain in their jar.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Daily Balance Gummy | Experimental | Dietary Supplement: Daily Balance GummyOne Daily Balance Gummy should be taken with the last meal of the day. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 40-65 years old Must 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, irregular or absent periods, or vaginal changes Must experience hot flashes and/or night sweats at least 5 times per day Can be either natural or surgical menopause (or perimenopause) Willing to adhere to the study protocol for the duration of the study
- Willing to consult with their physician prior to starting the trial if taking any of the following medications:
- Levothyroxine Liothyronine Calcipotriene (Dovonex) Digoxin (Lanoxin) Diltiazem (Cardizem) Verapamil (Calan, others) Thiazide diuretics Atorvastatin (Lipitor) Warfarin - Might increase the amount of time it takes for blood clotting. Minosalicylic acid (Paser) Colchicine (Colcrys, Mitigare, Gloperba) Metformin (Glumetza, Fortamet, others) Proton pump inhibitors (omeprazole (Prilosec), lansoprazole (Prevacid) or other stomach acid-reducing drugs) Phenytoin (Dilantin) Antihypertensive drugs Phenobarbital (Luminal) Amiodarone (Cordarone) Levodopa
Key exclusion criteria (1 listed)
- Not experiencing hot flashes and/or night sweats at least 5 times per day Has taken herbal supplements or multivitamins within the last 1 month 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 to any product ingredients including the purified isoflavone genistein 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 No planned invasive medical procedures for the duration of the study Pregnant or breastfeeding
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 |
|---|---|---|
| Daily Balance GummyPhenology Daily Balance Gummies 30 ct. Yuzu Tangerine Flavor. Product contains Vitamin D2, Vitamin K2, Vitamin B6, Vitamin B12, Biotin, Genistein, Saffron Extract, Organic Tapioca Syrup, Organic Cane Sugar, Water, Pectin, Citric Acid, Natural Flavors. | Dietary supplement | Daily Balance Gummy |
Primary outcome
Changes in score on the Menopause Rating Scale (MRS). [Baseline to Week 12]
Time frame: 12 weeks
The Menopause Rating Scale (MRS) is a commonly used assessment tool in medical and research settings to evaluate the severity and impact of menopausal symptoms on women's lives. 5 point Likert scale, with the following points relating to menopausal symptoms: 0 - None (absent) 1. - Mild (light) 2. - Moderate (medium) 3. - Severe (heavy) 4. - Very severe (very heavy)
Change in hot flashes. [Baseline to Week 12]
Time frame: 12 weeks
Survey-based assessment (0-5 point scale) of changes in hot flashes. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('Extremely often') and 5 representing the most beneficial response (i.e., "never").
Change in night sweats. [Baseline to 12 Weeks]
Time frame: 12 weeks
Survey-based assessment (0-5 point scale) of changes in night sweats. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Change in brain fog. [Baseline to Week 12]
Time frame: 12 weeks
Survey-based assessment (0-5 point scale) of changes in brain fog. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Change in mood swings. [Baseline to Week 12]
Time frame: 12 weeks
Survey-based assessment (0-5 point scale) of changes in mood swings. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Change in sleep disturbances. [Baseline to Week 12]
Time frame: 12 weeks
Survey-based assessment (0-5 point scale) of changes in sleep disturbances. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
Change in fatigue. [Baseline to Week 12]
Time frame: 12 weeks
Survey-based assessment (0-5 point scale) of changes in fatigue. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
1 secondary outcome
Changes in participant-reported quality of life. [Baseline to Week 12]
Time frame: 12 weeks
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 29 Feb 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 Daily Balance Gummy in people with Menopause and Perimenopause, run by Hologram Sciences 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 3 inclusion and 1 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 29 Feb 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. 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?
Changes in score on the Menopause Rating Scale (MRS). [Baseline to Week 12] (time frame: 12 weeks). The study lists 7 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 29 Feb 2024.