Recruiting

Oral Dietary SupplementA Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Panelists With Menopausal Symptoms Including Vasomotor Symptoms (VMS).

Sponsor:

Olly, PBC

Code:

NCT07033013

Conditions

Healthy

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Accepted

Interventions

Placebo

Dietary Supplement with actives

Study Details

Brief summary:

Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement

Conditions

Healthy

Study ID

NCT07033013

Start date

Jul 7, 2025

Status verified date

Jul, 2025

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Jul 25, 2025

Anticipated

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

Healthy Females aged 40 to 65 years
Self-reporting menopausal symptoms (> 5 hot flashes 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
NORMAL BMI (per metropolitan life tables): under 30 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.

Exclusion Criteria:

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 panelist's health under risk, such as: thyroid disease, diabetes mellitus, history of hormone dependent (gynecological) cancer, endometrial hyperplasia, uterine cancer, endometrial cancer, drug and alcohol abuse, mental disorder, abnormality in renal and liver functions, personal or family history of breast cancer in a first degree relative, and history of clotting disorder such as deep vein thrombosis.)
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 or drugs
Uncontrolled hypertension (160/100 mmHg or higher, measured after 10 min of seated rest)
Oophorectomy or amenorrhea > two years.
Participating in a different clinical trial within one month of the start of this clinical trial or planning to participate in another clinical trial during the trial period
Continuous intake of foods based on Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai within the past month
Employees of the institute or the brand owner or the manufacturers of the product
Note: Habitual medicine and supplement intake will be registered prior to inclusion in the study

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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.

active comparator: Dietary Supplement with actives

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.

Interventions

Placebo

Dietary Supplement with actives

Dietary supplement containing EstroG-100 and GABA

Primary outcome measure

24 hour effects following single dose of Mellow Menopause - Hot Flashes [ Time Frame: From baseline Day 7 to Treatement Day 1 (Day 8 of study) ]

Central Contacts and Locations

Locations

San Francisco Research Institute

Recruiting

San Francisco, California, United States, 94132

Contacts

John Ademola

jademola@sfinstitute.com

More Information

Sponsor

Olly, PBC

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Olly, PBC on 2025-07-16.