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

NCT07146321 | Not Yet Recruiting

• 1 other identifier: AFCRO-196
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Secondary Outcomes (11)

• Sexual symptoms of menopause

  12 weeks

• Physical symptoms of menopause

  12 weeks

• Vasomotor symptoms of menopause

  12 weeks

• Sleep related impairment

  12 weeks

• Impact to stress

  12 weeks

Study Arms (2)

multi-vitamin, multi-nutrient supplement

ACTIVE COMPARATOR

Dietary Supplement: multi-vitamin, multi-nutrient

placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

multi-vitamin, multi-nutrient DIETARY_SUPPLEMENT

A multi-vitamin, multi-nutrient combination of approved and/or GRAS ingredients

multi-vitamin, multi-nutrient supplement

Placebo DIETARY_SUPPLEMENT

placebo

placebo

Eligibility Criteria

• Age: 43 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Biologica Inc: lead

Study Sites (1)

Atlantia Clinical Trials

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Geritol

Central Study Contacts

Andre Doolan

CONTACT

+353 21 430 7442; adoolan@atlantiatrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2025
• Primary Completion: March 9, 2026
• Study Completion: April 5, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)