Multivitamin + Multi-nutrient Supplement for Menopause

Overseen By Andre Doolan

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Biologica Inc

Must not be taking: Hypnotics, Psychotropics, Steroids, others

Disqualifiers: Pregnancy, Alcohol abuse, Smoking, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a multivitamin and multi-nutrient supplement can improve mental and emotional well-being in women experiencing menopause symptoms. The study compares the effects of the supplement against a placebo (a pill with no active ingredients) to identify any differences. Women who have experienced anxiety, sleep difficulties, or fatigue in the past year may be suitable candidates for this study. Participants must be comfortable using a wearable device for tracking during the trial.

As an unphased trial, this study provides a unique opportunity to contribute to understanding how supplements might alleviate menopause symptoms.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants who have used specific medications like sleep aids, anxiety or depression treatments, and steroids in the past 12 weeks, as well as certain supplements in the past week.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that multivitamin and multi-nutrient supplements are usually safe for most people. Studies have found that these supplements generally don't cause major side effects. However, excessive intake of certain nutrients, such as vitamin A and manganese, can be harmful. It's important to adhere to the recommended amounts.

Although multivitamins are often researched for their health benefits, they have not been proven to significantly impact common health issues like cancer or heart disease in women. This suggests that while they might not offer substantial health benefits, they are also unlikely to cause harm if used correctly. Consulting a healthcare provider before starting any new supplement is always advisable for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the multi-vitamin and multi-nutrient supplement for menopause because it offers a holistic approach that could complement or even enhance current hormone-based treatments. Unlike standard hormone replacement therapies, which primarily focus on replenishing estrogen and progesterone levels, this supplement aims to support overall health and well-being by addressing potential nutrient deficiencies that may exacerbate menopause symptoms. By incorporating a range of essential vitamins and nutrients, this treatment has the potential to improve energy levels, mood, and bone health, offering a more comprehensive solution with fewer side effects.

What evidence suggests that this treatment might be an effective treatment for menopause?

Research has shown that certain vitamins can enhance life for menopausal women. One study found that high weekly doses of vitamin D greatly improved overall well-being. Other research indicates that multivitamins can boost levels of vitamin D and folate, which are important for health. In this trial, participants will receive either a multivitamin and multi-nutrient supplement or a placebo. Early findings suggest that the multivitamin and multi-nutrient supplement might alleviate symptoms like mood swings, as participants demonstrated improvements in mental and emotional symptoms compared to those receiving a placebo. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy females aged 43 to 55 who are going through peri-menopause or menopause. Participants should be experiencing symptoms related to these stages but otherwise in good health.

Inclusion Criteria

Has a minimum of 7 days of Oura ring data

Willing to consume the Study Product daily for the duration of the study

Be able to give written informed consent

Exclusion Criteria

Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding

Drinks more than nationally recommended units of alcohol per day/week

Participants currently of biological childbearing potential, but not using a continuous effective method of contraception

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multivitamin, multi-nutrient supplement or placebo for 12 weeks to assess changes in mental and emotional wellbeing

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multi-vitamin, multi-nutrient

Trial Overview The study tests the impact of a multivitamin, multi-nutrient supplement on mental and emotional wellbeing compared to a placebo. It's randomized and double-blinded, meaning neither participants nor researchers know who gets the real supplement.

How Is the Trial Designed?

Group I: multi-vitamin, multi-nutrient supplement Active Control 1 Intervention

Group II: placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Biologica Inc

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6372850/

Selected vitamins and quality of life in menopausal women The obtained results suggested that 40,000 IU of vitamin D supplemented weekly significantly improved quality of life. On the other hand, Grimnes et al. [35] ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07146321

A Study to Investigate the Effect of a Multivitamin, Multi ... Change in mental and emotional symptoms in menopause in the multivitamin, multi-nutrient supplement group compared to Placebo. Assessed by the Menopause ...

3. ods.od.nih.gov ods.od.nih.gov/factsheets/MVMS-HealthProfessional/

Multivitamin/mineral Supplements - Health Professional ... The greatest improvements in intake were for vitamins A and E and zinc. However, MVM users had excessive intakes of several nutrients; 10%–15% ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2021.610382/full

Effects of 12-Week Multivitamin and Omega-3 ... This study demonstrates that MV supplementation was effective at increasing serum vitamin D and folate levels, and favorably altering red blood ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037851221000229X

A review of select vitamins and minerals used by ... This review focuses on the effects of vitamin and mineral supplementation in postmenopausal women with an emphasis on bone health, cardiovascular health, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523279125

What is known about the safety of multivitamin-multimineral ... Certain nutrients such as vitamin A and manganese have known and potentially serious adverse effects at high intakes, whereas others such as iron or vitamin C ...

7. health.harvard.edu health.harvard.edu/womens-health/menopause-supplements-effective-relief-or-empty-promises

Menopause supplements: Effective relief or empty promises? Advice to consider. Dr. Cohen advises women to steer clear of any supplement marketed for menopausal symptoms. But if you decide to consider ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/414784

Multivitamin Use and Risk of Cancer and Cardiovascular ... The Women's Health Initiative study provided convincing evidence that multivitamin use has little or no influence on the risk of common cancers, CVD, or total ...