Probiotic supplementation on subjective ratings of menopause and markers of health in post-menopausal women. Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will be randomized into one of the three treatment groups listed below
1. Placebo (PLA)
2. Treatment 1 - 5 billion CFU Multi-Strain Probiotic (PRO, 2 billion CFU Lacticaseibacillus rhamnosus CA 15, 1 billion CFU Bifidobacterium animalis lactis BLC1, 1 billion CFU, Limos
Sponsors
Increnovo
Eligibility
Sex/Gender
Female
Age
41 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Women (>40 years of age) with a BMI on average < 30 kg/m² and a max individual BMI = 32 kg/m². 2. Women who are postmenopausal as defined by the Stages of Reproductive Aging Workshop (STRAW) criteria (i.e., at least 12 months amenorrheic) and experiencing menopause-related symptoms (e.g., vaginal dryness, hot flashed, night sweats, sleep problems, mood changes, memory issues, etc.) 3. Participant agrees to maintain their normal dietary, activity patterns throughout the study period. 4. Participant agrees to refrain from alcohol, caffeine, and strenuous exercise for 24 hours prior to each testing day. 5. Participant agrees to refrain from consuming probiotic, prebiotic (e.g., fiber, omega-3 fatty acids), and phytoestrogen-based supplements outside of the study for the duration of the study period. 6. Participant is willing and able to comply with the study protocol. 7. Participant has given voluntary, written, informed consent to participate in the study. 8. Participant will be allowed to take current medications as long as it is not believed to affect study outcomes.
Exclusion criteria
Exclusion criteria: 1. Women (>40 years of age) who are not postmenopausal as defined by Stages of Reproductive Aging Workshops (STRAW) criteria (i.e., at least 12 months amenorrheic). 2. Women who are postmenopausal but not experiencing symptoms. 3. Women on Hormone Replacement Therapy (HRT). 4. Women who are determined to have lever, renal, cardiovascular, or other metabolic disease. 5. Women who have a known allergy or sensitivity to probiotic supplements. 6. Women who are pregnant, breast feeding, or planning to become pregnant during the trial. 7. Women who have used antibiotics or antifungals within three months prior to enrollment, including topical antibiotics or antifungals. 8. Women who have a clinically significant abnormal laboratory results at the screening visit. 9. Women who have used tobacco or nicotine products in the past 12 months prior to starting the study. 10. Women who have Type I or Type II diabetes mellitus or on treatment with anti-diabetic medication. 11. Women who have unstable metabolic diseases or chronic diseases. 12. Women who have documented or self-reported current or pre-existing thyroid conditions. 13. Women who have unstable hypertension. 14. Women with current or a history of any significant diseases of the gastrointestinal tract (including but not limited to inflammatory bowel disease and diverticulosis). 15. Women with a current use of any probiotic, prebiotic, and synbiotic product unless they are willing to undergo a 4-week washout period to run-in period and abstain from consuming such products during the study. 16. Women who use cannabinoid products (including synthetics) within one month of study entry or during the study. 17. Women who use alcohol or have abused drugs within the last 12 months. 18. Women who report a high alcohol intake (average of > 2 standard drinks per day or > 10 standard drinks per week). 19. Women who report the use of other dietary supplements to address menopausal symptoms. 20. Women who have donated blood 30 days prior to screening, during the study, or have a planned donation within 30-days of the last study visit. 21. Women who have participated in other clinical research trials 30 days prior to the screening visit. 22. Any other conditions which, in the PI's opinion, may adversely affect the participant's ability to complete the study, its measurements, or pose a significant risk to the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Menopause Rating Scale (MRS) Questionnaire at 0,4,8,12 weeks 2. Menopause-Specific Quality of Life Questionnaire (MENQOL) at 0,4,8,12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Estrogen (blood test) at 0,4,8,12 weeks 2. Pittsburgh Sleep Quality Index (PSQI) at 0,4,8,12 weeks 3. Menopause Visual Analog Scale (VAS) Questionnaire at 0,4,8,12 weeks 4. Perceived Stress Scale (PSS) at 0,4,8,12 weeks 5. Patient-Reported Outcomes Measurement Information System (PROMIS) at 0,4,8,12 weeks 6. International Physical Activity Questionnaire (IPAQ) at 0,4,8,12 weeks 7. Complete Blood Count (CBC) at 0 and 12 weeks 8. Blood Chemistry Panel (Chem Panel) at 0 and 12 weeks 9. Blood Lipids (Lipid Panel) at 0 and 12 weeks 10. Blood Hemoglobin A1c (HBA1c) at 0 and 12 weeks 11. DXA body composition and bone density at 0 and 12 weeks 12. Side-Effects Assessment at 0,4,8,12 weeks | — |
Countries
United States of America
Contacts
Public ContactChristopher Rasmussen
Outcome results
None listed