Actively Recruiting

Phase Not Applicable
Age: 50Years - 70Years
FEMALE
Healthy Volunteers
ID07238478

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of JDS-HF3.0 in Menopause Related Quality of Life Outcomes in Postmenopausal Women

Led by Bonafide Health · Updated on 2025-11-20

250

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether taking the supplement JDS-HF3.0 can improve quality of life and lessen common menopause symptoms like joint discomfort, hot flashes, and night sweats in women aged 50 to 70. This study aims to find out if daily use of this product for 12 weeks reduces how often and how severe these menopausal symptoms are. About 250 postmenopausal women across the U.S. will take part in this randomized, placebo-controlled trial. Participants will be randomly assigned to one of two groups: one group takes the active JDS-HF3.0 supplement, and the other takes a nonactive placebo. Each participant will take two tablets every morning for about 12 weeks. The entire study lasts roughly 14 weeks, including the time spent collecting initial baseline information. All parts of the study are conducted virtually, with no in-person visits required. Throughout the study, participants will complete daily diaries and weekly or monthly questionnaires about their menopause symptoms and overall well-being. There will be five virtual check-ins including screening, baseline, two during the study, and a final visit. Researchers will monitor changes in menopause-related quality of life from enrollment to the end of the study at 12 weeks. This includes tracking symptom severity and frequency, with safety and adherence closely observed during the trial.

CONDITIONS

Brief Title

JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women

Who Can Participate

Age: 50Years - 70Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy biological females aged 50 to 70 years inclusive
  • Body mass index (BMI) between 18.5 and 34.9 kg/m2 inclusive
  • Postmenopausal for at least 12 months due to natural menopause, with menopausal symptoms for past 6 months
  • Moderate to severe menopause-related joint discomfort rated between 5 and 9 on a 0-10 scale
  • Experience at least 4 hot flashes on average per day
  • Good general health with no active or uncontrolled diseases
  • Able to consume the study product
  • Agree to avoid certain treatments during defined timeframes
  • Have reliable, stable access to Wi-Fi and a smartphone or device
  • Willing and able to consent, understand questionnaires, and complete all study procedures
Not Eligible

You will not qualify if you...

  • Lactating, pregnant, or planning pregnancy during the study
  • Currently participating in another clinical trial
  • Using treatments for menopausal symptoms or joint health that may interfere
  • Known allergy or intolerance to the study product or its ingredients
  • Use of glucosamine or chondroitin in past 3 months
  • Received COVID-19 vaccine within 2 weeks before screening or during study
  • Current COVID-19 infection or long COVID condition
  • History of heart, kidney, liver disease, or active systemic infections
  • Cancer history within 2 years except localized skin cancer without spread
  • Any significant disease that may increase risk or affect participation
  • Gastrointestinal, hepatic, or renal diseases affecting drug absorption or digestion
  • Difficulty swallowing or digestive tract abnormalities
  • Major surgery within 3 months before screening or planned during study
  • History of alcohol or substance abuse in past 5 years
  • Inflammatory rheumatic or autoimmune diseases
  • Chronic use of curcumin or curcuminoids unless willing to wash out for 3 months
  • Use of chronic pain medications or specific analgesics for joint discomfort unless willing to wash out for 2 weeks
  • Severe joint or bone deformities
  • Diagnosed bone fractures
  • Candidate for surgical joint replacement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (virtual)

Treatment

Duration - About 12 weeks

Participants take two tablets each morning of either the active supplement or placebo and complete symptom diaries and questionnaires to report on menopausal symptoms and quality of life.

4 virtual check-ins including baseline, two during treatment, and a final visit

Trial Site Locations

Total: 1 location

1

Bonafide Health

Harrison, New York, United States, 10528

Actively Recruiting

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Research Team

T

Trisha VanDusseldorp, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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