MenopauseNCT07146321
A Study to Investigate the Effect of a Multivitamin, Multi-nutrient Supplement on Mental and Emotional Wellbeing
A study testing multi-vitamin, multi-nutrient in people with Menopause, run by Biologica Inc at 1 site in United States.
Trial summary
This is a randomized, double-blinded, parallel, placebo-controlled study to investigate the effect of a multivitamin, multi-nutrient supplement on mental and emotional wellbeing in healthy females aged 43 to 55 years, experiencing peri-menopausal and menopausal symptoms Read more about this study
- Who is it for?
- Ages 43 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- multi-vitamin, multi-nutrient
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 5 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 43 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be able to give written informed consent.
- Be between 43 and 55, inclusive.
- Experiencing a score of >4 on 3 of the symptoms below, within the past 12-months, measured by the MenQoL at Visit 1.
- feeling anxious or nervous
- difficulty sleeping
- feeling tired or worn out
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- being impatient with other people
- Ability to wear and interact with a wearable device (ring) for biomarker tracking.
- Has a minimum 7 days of Oura ring data
- Willing to consume the Study Product daily for the duration of the study.
Who cannot join
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
- Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), or tubal ligation. The Participant must be using this method for at least one week prior to and one week following the end of the study.
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- Use of any non-hormonal intrauterine device (IUD). The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
- Drinks more than nationally recommended units of alcohol per day/week. (Defined as <7 standard drinks per week, spread out over the week, with 2 to 3 alcohol-free days per week. Drinks no more than 3 standard drinks on any 1 occasion).
- Has a history of drug and/or alcohol abuse.
- Smoker
- Hypersensitivity that would preclude intake of the Study Products
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
- Uterine fibroids (current or previous 12 months)
- Polycystic ovarian syndrome
- Psychiatric disorders (e.g. bipolar, schizophrenia)
- Current or recent (in the past 12-weeks) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- Hypnotic-sedative drugs or sleep aids
- Psychotropics (e.g., treatment of anxiety, depression, ADHD etc.)
- Steroids (inhaled, intravenous, or oral).
- Current or recent (in the past 1-week) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:
- Supplements for the support of menopause symptoms (e.g., red clover, wild yam supplements/creams, ginseng, St John's Wort, DHEA supplements, Phytoestrogen supplements, hormone support supplements)
- Supplements that contain study product ingredients
- Supplements that support mood and sleep
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Study to Investigate the Effect of a Multivitamin, Multi-nutrient Supplement on Mental and Emotional Wellbeing in Females Aged 43 - 55 Years
This is a randomized, double-blinded, parallel, placebo-controlled study to investigate the effect of a multivitamin, multi-nutrient supplement on mental and emotional wellbeing in healthy females aged 43 to 55 years, experiencing peri-menopausal and menopausal symptoms
- Conditions
- Menopause
- Being tested
- multi-vitamin, multi-nutrient, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-vitamin, multi-nutrientDietary supplement
A multi-vitamin, multi-nutrient combination of approved and/or GRAS ingredients
PlaceboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| multi-vitamin, multi-nutrient supplement | Active comparator | Not described Receives: Dietary Supplement: multi-vitamin, multi-nutrient |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial symptoms associated with menopause
Change in mental and emotional symptoms in menopause in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the Menopause-specific Quality of Life Questionnaire (MenQoL) - psychosocial domain score. Baseline to end of intervention (week 12).
Measured: 12 weeks
Secondary outcomes (11)
Sexual symptoms of menopause
Change in sexual symptoms of menopause (sexual desire, vaginal dryness, and satisfaction) in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the Menopause-specific Quality of Life Questionnaire (MenQoL) - sexual domain score. Baseline to end of intervention (week 12)
Measured: 12 weeks
Physical symptoms of menopause
Change in physical symptoms of menopause (fatigue, sleep disturbances, aches and pains, weight gain, and changes in skin or hair) in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the Menopause-specific Quality of Life Questionnaire (MenQoL) - physical domain score. Baseline to end of intervention (week 12)
Measured: 12 weeks
Vasomotor symptoms of menopause
Change in vasomotor symptoms of menopause (hot flashes, night sweats, and sweating) in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the Menopause-specific Quality of Life Questionnaire (MenQoL) - vasomotor domain score. Baseline to end of intervention (week 12)
Measured: 12 weeks
Sleep related impairment
Change in sleep related impairment (alertness, sleepiness, and tiredness during waking hours) in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the PROMIS® Sleep-Related Impairment - Total Score. Baseline to end of intervention (week 12)
Measured: 12 weeks
Impact to stress
Change in stress in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the DASS-21 - stress score. Baseline to end of intervention (week 12)
Measured: 12 weeks
Impact to anxiety
Change in anxiety in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the DASS-21 - anxiety score. Baseline to end of intervention (week 12)
Measured: 12 weeks
Impact to working memory
Change in memory disturbances in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the Everyday Memory Questionnaire-Revised (EMQ-R) - Total score. Baseline to end of intervention (week 12)
Measured: 12 weeks
Impact to sleep efficiency
Change in sleep quality and patterns in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by percentage sleep efficiency, measured using the Oura ring. Baseline to end of intervention (week 12)
Measured: 12 weeks
Impact to sleep latency
Change in sleep quality and patterns in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by sleep latency in minutes, measured using the Oura ring. Baseline to end of intervention (week 12)
Measured: 12 weeks
Impact to total sleep time
Change in sleep quality and patterns in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by total sleep-in minutes, measured using the Oura ring. Baseline to end of intervention (week 12)
Measured: 12 weeks
Impact to sleep disturbances
Change in sleep quality and patterns in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by sleep disturbance as events per hour, measured using the Oura ring. Baseline to end of intervention (week 12)
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 posted28 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion9 Mar 2026 (estimated)
- Study completion5 Apr 2026 (estimated)
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biologica Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146321
- Sponsor's protocol ID
- AFCRO-196
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Study to Investigate the Effect of a Multivitamin, Multi-nutrient Supplement on Mental and Emotional Wellbeing in Females Aged 43 - 55 Years
- ClinicalTrials.gov ID
- NCT07146321
- Acronym / sponsor ID
- AFCRO-196
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Biologica IncIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 9 Mar 2026 (estimated)
- Study completion
- 5 Apr 2026 (estimated)
- First posted
- 28 Aug 2025 (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.
This is a randomized, double-blinded, parallel, placebo-controlled study to investigate the effect of a multivitamin, multi-nutrient supplement on mental and emotional wellbeing in healthy females aged 43 to 55 years, experiencing peri-menopausal and menopausal symptoms
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multi-vitamin, multi-nutrient supplement | Active comparator | Dietary Supplement: multi-vitamin, multi-nutrient |
| placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 43 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be able to give written informed consent.
- Be between 43 and 55, inclusive.
- Experiencing a score of >4 on 3 of the symptoms below, within the past 12-months, measured by the MenQoL at Visit 1.
- Ability to wear and interact with a wearable device (ring) for biomarker tracking.
- Has a minimum 7 days of Oura ring data
Key exclusion criteria (25 listed)
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Drinks more than nationally recommended units of alcohol per day/week. (Defined as <7 standard drinks per week, spread out over the week, with 2 to 3 alcohol-free days per week. Drinks no more than 3 standard drinks on any 1 occasion).
- Has a history of drug and/or alcohol abuse.
- Smoker
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 |
|---|---|---|
| multi-vitamin, multi-nutrientA multi-vitamin, multi-nutrient combination of approved and/or GRAS ingredients | Dietary supplement | multi-vitamin, multi-nutrient supplement |
| Placeboplacebo | Dietary supplement | placebo |
Primary outcome
Psychosocial symptoms associated with menopause
Time frame: 12 weeks
Change in mental and emotional symptoms in menopause in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the Menopause-specific Quality of Life Questionnaire (MenQoL) - psychosocial domain score. Baseline to end of intervention (week 12).
11 secondary outcomes
Sexual symptoms of menopause
Time frame: 12 weeks
Physical symptoms of menopause
Time frame: 12 weeks
Vasomotor symptoms of menopause
Time frame: 12 weeks
Sleep related impairment
Time frame: 12 weeks
Impact to stress
Time frame: 12 weeks
Impact to anxiety
Time frame: 12 weeks
Impact to working memory
Time frame: 12 weeks
Impact to sleep efficiency
Time frame: 12 weeks
Impact to sleep latency
Time frame: 12 weeks
Impact to total sleep time
Time frame: 12 weeks
Impact to sleep disturbances
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-vitamin, multi-nutrient in people with Menopause, run by Biologica Inc 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 25 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: opening soon, as of the sponsor's last update on 28 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre Doolan (+353 21 430 7442, adoolan@atlantiatrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial symptoms associated with menopause (time frame: 12 weeks). 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 28 Aug 2025.