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A Study to Investigate the Effect of a Multivitamin, Multi-nutrient Supplement on Mental and Emotional Wellbeing | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

A Study to Investigate the Effect of a Multivitamin, Multi-nutrient Supplement on Mental and Emotional Wellbeing

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

NCT07146321•Biologica Inc

View on ClinicalTrials.gov

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

Eligibility

Age

43 - 55 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Be able to give written informed consent.
•2. Be between 43 and 55, inclusive.
•3. Experiencing a score of \>4 on 3 of the symptoms below, within the past 12-months, measured by the MenQoL at Visit 1.
•1. feeling anxious or nervous
•2. difficulty sleeping
•3. feeling tired or worn out
•4. being impatient with other people
•4. Ability to wear and interact with a wearable device (ring) for biomarker tracking.
•5. Has a minimum 7 days of Oura ring data
•6. Willing to consume the Study Product daily for the duration of the study.

Exclusion Criteria

•1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
•2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
•1. 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).
•2. Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
•3. Sexual partner(s) is/are exclusively female.
•4. 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.
•5. 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.
•3. 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).
•4. Has a history of drug and/or alcohol abuse.
•5. Smoker
+15 more criteria

Locations (1)

Atlantia Clinical Trials

Chicago, Illinois, United States

Key Dates

Start Date

September 1, 2025

Primary Completion Date

March 9, 2026

Completion Date

April 5, 2026

Last Updated

August 28, 2025

Enrollment

ESTIMATED participants

Conditions

Menopause

Interventions

multi-vitamin, multi-nutrient

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Contacts

Andre Doolan

CONTACT

+353 21 430 7442 adoolan@atlantiatrials.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate the Effect of a Multivitamin, Multi-nutrient Supplement on Mental and Emotional Wellbeing

Inclusion Criteria

Exclusion Criteria

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