Atlantia Clinical Trials
Chicago, Illinois, 60611, United States
NCT Number: NCT07146321
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
Trial opening soon.
Get Notified43 year–55 year
Female
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A multi-vitamin, multi-nutrient combination of approved and/or GRAS ingredients
placebo
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).
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Contact information is provided by the study sponsor or research team.
Biologica Inc
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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