A Study to Evaluate the Efficacy of a Postbiotic Supplement on Menopausal Symptoms in Premenopausal Women

NCT07570043 | Active Not Recruiting

• 1 other identifier: ABL-032503
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this consumer study is to evaluate the efficacy of a postbiotic supplement on menopausal symptoms and hormonal balance in premenopausal women ages 35-55 (inclusive) who are generally healthy. The main question it aims to answer is: Will the postbiotic supplement improve menopausal symptoms in premenopausal women? If there is a comparison group: Researchers will compare placebo and active supplement to see if there is a statistically significant difference in effect. Participants will take the supplement/placebo daily for 8 weeks and complete questionnaires on a regular basis.

Conditions

Premenopause

Outcome Measures

Primary Outcomes (2)

• Improvement in menopausal symptoms

  8 weeks

• Changes in gut microbiota composition associated with hormonal health

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Supplement

EXPERIMENTAL

Dietary Supplement: Supplement

Interventions

Supplement DIETARY_SUPPLEMENT

Active supplement

Supplement

Placebo OTHER

Inactive supplement

Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide voluntary signed and dated informed consent
• Age between 35 and 55 years (inclusive)
• Have normal or acceptable vital signs (blood pressure and heart rate) and normal or acceptable physical exam findings at screening.
• Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
• Subject is willing and able to comply with the study protocol.
• Females of childbearing potential must agree to practice a medically acceptable form of birth control throughout the study.
• Agree to refrain from other probiotic, prebiotic, hormonal, or menopause-support supplements during the duration of the trial.

You may not qualify if:

• History of gynecological diseases or conditions.
• Current use of hormone replacement therapy (HRT).
• History of unstable or new-onset cardiovascular, renal, hepatic, or significant metabolic disorders.
• Known gastrointestinal conditions affecting absorption or metabolism.
• Pregnancy, lactation, or planning pregnancy during the study.
• Known sensitivity to any ingredient in the test formulations.
• Currently participating in another research study with an investigational product or have participated in another research study in the past 30 days.
• Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
• Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Sponsors & Collaborators

• Able Biolabs, LLC: lead

Study Sites (1)

Able Biolabs LLC

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)