One Week Clinical Study in Subjects With Menopausal Symptoms

NCT06794021 | Completed

• 1 other identifier: UNLV20241205
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms. The main questions it aims to answer are:

1. 1.To assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through Daily Diary and Mobile Application
2. 2.To assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 Daily Diary and Mobile Application
3. 3.To assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of Daily Diary, Mobile Application and validated questionnaires (GCS, MENQOL).
4. 4.To assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (PSQI, PSS, POMS)

Conditions

Healthy; Menopause

Outcome Measures

Primary Outcomes (2)

• Daily Diary - 24hr

  To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Daily Diary.

  from enrollment to the end of study at seven days

• Mobile App - 24hr

  To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Mobile Application.

  from enrollment to the end of study at seven days

Secondary Outcomes (4)

• Daily Dairy - Days 1-6

  from enrollment to the end of study at seven days

• Mobile App - Days 1-6

  from enrollment to the end of study at seven days

• Green Climacteric Scale (GCS) - Days 1-6

  from enrollment to the end of study at seven days

• Menopause-Specific Quality of Life (MENQOL) - Days 1-6

  from enrollment to the end of study at seven days

Other Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI) - Day 7

  from enrollment to the end of study at seven days

• Perceived Stress Scale (PSS) - Day 7

  from enrollment to the end of study at seven days

• Profile of Mood States questionnaire (POMS) - Day 7

  from enrollment to the end of study at seven days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Oral dietary supplement. Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

Other: Placebo

Dietary Supplement with Proprietary Herbal Extract Blend and GABA

ACTIVE COMPARATOR

Oral dietary supplement. Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

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

Interventions

Dietary Supplement with Proprietary Herbal Extract Blend and GABA DIETARY_SUPPLEMENT

Eligible subjects will receive active product to take daily for seven days

Dietary Supplement with Proprietary Herbal Extract Blend and GABA

Placebo OTHER

Eligible subjects will receive Placebo to take daily for seven days

Placebo

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 or the brand owner or the manufactures of the product
• 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
• Use of other menopause supplements
• BP ≥160/110 mmHg

Sponsors & Collaborators

• Olly, PBC: lead

Study Sites (1)

San Francisco Research Institute

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
• Masking Details: Double-Blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 27, 2025
• Study Start: January 21, 2025
• Primary Completion: January 31, 2025
• Study Completion: April 22, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)