Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women

NCT05813067 | Completed

• 1 other identifier: B01-22-01-T0032
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

Brief Summary

The role of nutrition is recognized as a vital component to healthy aging throughout menopause. The goal of this study is to evaluate a dietary supplement for its safety and effects on vasomotor symptoms in menopausal women.

Conditions

Vasomotor Symptoms; Postmenopausal Disorders

Keywords

Vasomotor Symptoms; Menopause; Women's Health

Outcome Measures

Primary Outcomes (1)

• To determine the effects of the Test Product (TP) compared to placebo on hot flash symptoms as determined by the Hot Flash Related Daily Interference Scale (HFRDIS).

  Change from baseline for the number and severity of hot flashes measured by HFRDIS scores. The HFRDIS has a scoring range of 0-100, with higher values indicating worse symptoms.

  12 weeks

Secondary Outcomes (4)

• To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Greene Climacteric Scale (GCS).

  12 weeks

• To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Menopausal Rating Scale (MRS).

  12 weeks

• To determine the effect of the TP compared to the placebo on sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).

  12 weeks

• To determine the effect of the TP compared to the placebo on quality of life as determined by the Menopause-Specific Quality of Life (MENQOL) questionnaire.

  12 weeks

Other Outcomes (1)

• To assess the safety and tolerability of the TP compared to the placebo in healthy participants.

  12 weeks

Study Arms (2)

Test Product: JDS-HF3.0 Capsules

EXPERIMENTAL

Dietary supplement containing a proprietary botanical blend with NK3R antagonistic activity

Dietary Supplement: JDS-HF 3.0

Placebo Capsules

PLACEBO COMPARATOR

Placebo capsule containing: * Microcrystalline cellulose * Silicon dioxide micronized * Magnesium stearate

Dietary Supplement: Placebo

Interventions

JDS-HF 3.0 DIETARY_SUPPLEMENT

Take 2 capsules once daily in the mornings with food

Test Product: JDS-HF3.0 Capsules

Placebo DIETARY_SUPPLEMENT

Take 2 capsules once daily in the mornings with food

Placebo Capsules

Eligibility Criteria

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

You may qualify if:

• Healthy menopausal women who are 40 to 65 years of age (inclusive).
• Last menstrual period has occurred at least 6 months prior to screening.
• MRS score ≥2 at screening and at baseline.
• Have self-reported menopausal symptoms for the past 6 months.
• Have self-reported at least five moderate to severe hot flashes per day (including night sweats), on average for 7 days
• Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
• In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
• Have normal vital signs or acceptable to the investigator vital signs (blood pressure and heart rate) at screening.
• Agree to refrain from treatments for hot flashes and other symptoms of menopause.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if:

• Individuals who are lactating, pregnant or planning to become pregnant during the study.
• Induced menopause through surgery such as bilateral oophorectomy or salpingo-oophorectomy, chemotherapy, radiation, or drugs.
• Individuals who have had a partial or total hysterectomy.
• Use of any treatment for menopausal symptoms or other concomitant treatments listed under the "concomitant therapies" section of the protocol
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
• Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (e.g., lyme disease, TB, HIV).
• Have uncontrolled high blood pressure (≥160 mmHg systolic or ≥100 mmHg diastolic) or thyroid disease, defined as not taking a stable dose of medication on the current regimen for a minimum of three months.
• Have diabetes (Type I or Type II).
• History of cancer (except localized skin cancer without metastases) within five (5) years prior to screening. Note: all women with breast cancer (active or any history) will be excluded.
• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.
• History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency).
• Active vaginal infections/abnormalities (e.g., active urinary tract infection (UTI), genital hemorrhage of unknown origin, pelvic inflammatory disease (PID)). Note: screened participants with infections would be eligible to participate four weeks after completing their treatment (wash-out period).
• Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
• Major surgery in three months prior to screening or planned major surgery during the study.

Sponsors & Collaborators

• Bonafide Health: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (3)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35205, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Rosemark WomenCare

Idaho Falls, Idaho, 83404, United States

Location

Study Officials

• Samuel N Lederman, MD

  Altus Research

  PRINCIPAL INVESTIGATOR

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

Model Details: Randomized, double-blinded, placebo-controlled, parallel

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 14, 2023
• Study Start: December 27, 2022
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)