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

NCT ID: NCT06148714

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-06-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Provitalize Probiotic

Participants will take 2 capsules every morning on an empty stomach before their first meal of the day.

Group Type: EXPERIMENTAL

Provitalize Natural Menopause Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Supplement containing a Probiotic blend of Bifidobacterium breve, Lactobacillus Gasseri, and Bifidobacterium animalis subsp. Lactis.

Placebo

Participants will take 2 capsules every morning on an empty stomach before their first meal of the day.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo comparator containing Pure hydroxypropyl methylcellulose (HPmC) with food dye.

Interventions

Provitalize Natural Menopause Probiotic

Supplement containing a Probiotic blend of Bifidobacterium breve, Lactobacillus Gasseri, and Bifidobacterium animalis subsp. Lactis.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo comparator containing Pure hydroxypropyl methylcellulose (HPmC) with food dye.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women aged 45-65 years old
• Must experience hot flashes and/or night sweats at least once per day
• Must also be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes
• Can be either natural or surgical menopause
• Has not had a period in the last 12 consecutive months
• Willing to adhere to the study protocol for the duration of the study
• Willing to stop taking any other herbal remedies or supplements for the duration of the study
• Self-reports as "generally healthy"
• Has never taken Provitalize before
• No planned invasive medical procedures for the duration of the study or in the three weeks leading up to the study start

Exclusion Criteria

• Not experiencing hot flashes and/or night sweats at least once per day and two other symptoms of menopause such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes
• Unwilling to stop taking any other herbal remedies or supplements for the duration of the study
• Current use of conventional hormone replacement therapies, or plan to start during the study duration
• Current use of hormonal birth control, or plan to start during the study duration
• Known allergies or hypersensitivities to any product ingredients
• Current or history of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear
• Anyone with any known severe allergies requiring the use of an epi-pen
• Unwilling to adhere to the study protocol
• Anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders
• Pregnant, breastfeeding or trying to conceive
• Currently taking a prescription sleep aid

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Maneuver Marketing

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20379

Identifier Type: -

Identifier Source: org_study_id