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

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

Overview

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

Interventions

• Dietary supplement multi-vitamin, multi-nutrient
  A multi-vitamin, multi-nutrient combination of approved and/or GRAS ingredients
• Dietary supplement Placebo
  placebo

Primary outcome measures

• Psychosocial symptoms associated with menopause [Time frame: 12 weeks]

Secondary outcome measures (11)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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)
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

United States · 1 center

• Atlantia Clinical Trials — Chicago

Identifiers

NCT: NCT07146321 · AFCRO-196

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗