Randomized Placebo Controlled Clinical Study of an Oral Product in Subjects With Menopausal Symptoms

NCT06787443 | Completed

• 1 other identifier: UNLV20240222
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.

Conditions

Menopausal Symptoms

Outcome Measures

Primary Outcomes (2)

• Changes of symptom scores in Daily Dairy

  To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects

  from enrollment to the end of study at five weeks

• Changes of symptom scores in Mobile Application

  To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects

  from enrollment to the end of study at five weeks

Secondary Outcomes (5)

• Changes in Menopause-Specific Quality of Life (MENQOL) Scores

  from enrollment to the end of study at five weeks

• Changes in Green Climacteric Scale (GCS) Scores

  from enrollment to the end of study at five weeks

• Changes in Perceived Stress Scale (PSS) Scores

  from enrollment to the end of study at five weeks

• Changes in Profile of Mood States (POMS) Scores

  from enrollment to the end of study at five weeks

• Changes in Pittsburgh Sleep Quality Index (PSQI) Scores

  from enrollment to the end of study at five weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Dietary Supplement with Actives

ACTIVE COMPARATOR

Dietary Supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA

Interventions

Placebo DIETARY_SUPPLEMENT

Eligible subjects will receive Placebo to take daily for five weeks

Placebo

Dietary Supplement with Proprietary Herbal Extract Blend and GABA DIETARY_SUPPLEMENT

Eligible subjects will receive active product to take daily for five weeks

Dietary Supplement with Actives

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Females aged 40 to 65 years,
• Self-reporting menopausal symptoms (\> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit.
• Reporting a variable cycle length of \> 7 days different from normal
• BMI 20-40 kg/m2
• Able to read, understand, and complete the study questionnaire and records.
• Able to understand the study procedures.
• Able to comply with all study requirements.
• Written informed consent to participate in the study.
• Willingness to actively participate in the study and to come to the scheduled visits.

You may not qualify if:

• Pregnancy or breastfeeding.
• Immune insufficiency
• Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
• History of hysterectomy
• Women on hormone replacement therapy
• Use of systemic corticosteroids or immunosuppressant drugs.
• Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
• Employees of the institute
• Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
• Alcohol or drug abuse,
• Use of hormonal contraceptives within the last 3 months
• BP ≥160/110 mmHg
• Oophorectomy or amenorrhea \> two years

Sponsors & Collaborators

• Olly, PBC: lead

Study Sites (1)

See Final Report

San Francisco, California, 94127, United States

Location

MeSH Terms

Interventions

Dietary Supplements; gamma-Aminobutyric Acid

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: January 22, 2025
• Study Start: May 10, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

US (1)