NCT06148714

A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Maneuver Marketing · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Symptoms of menopause can significantly affect overall quality of life. It is hypothesized that probiotic supplements can reduce the severity of these symptoms. This 90-day randomized controlled trial will examine the effects of the Provitalize Natural Menopause Probiotic on weight loss, waist circumference, sleep, and symptoms of menopause including hot flashes, night sweats, mood swings, anxiety, fatigue and brain fog. Participants will take either the test product or a placebo daily. All participants will complete study-specific questionnaires and provide sleep data from their Fitbit at Baseline, Day 30, Day 60 and Day 90. At Baseline, Day 30, Day 60 and and Day 90, participants will also provide a bodyweight measurement and a waist circumference measurement.

Conditions

• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Provitalize Natural Menopause Probiotic	Supplement containing a Probiotic blend of Bifidobacterium breve, Lactobacillus Gasseri, and Bifidobacterium animalis subsp. Lactis.
OTHER	Placebo	Placebo comparator containing Pure hydroxypropyl methylcellulose (HPmC) with food dye.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-06-15
• Completion: 2024-06-15
• First posted: 2023-11-28
• Last updated: 2024-11-20

Locations

1 site across 1 country: United States