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

What this trial studies

The goal of this interventional study is to evaluate whether the study product can help improve quality of life and reduce common menopause symptoms-such as joint discomfort, hot flashes and night sweats-in women aged 50-70. The primary research question is whether taking the study product daily for 12 weeks can reduce the severity and frequency of menopause-related symptoms.

Conditions in scope

• Joint Discomfort
• Joint Pain, Stiffness, Function
• Joint Pain
• Hot Flashes
• Hot Flash
• Night Sweats
• Vasomotor Symptoms

Interventions

• JDS-HF3.0 (Dietary Supplement) — Active Supplement JDS-HF3.0
• Placebo (Other) — Nonactive Placebo

Who can join

Women only · Ages 50 Years to 70 Years · Accepts healthy volunteers.

Inclusion criteria

• Healthy biological females who are 50-70 years of age (inclusive).
• Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
• Self-reported as postmenopause. Defined as 12 months without a menstrual cycle in individuals who undergo "Natural" Menopause (Not Surgically or medically induced) and who have self-reported menopausal outcomes for the past 6 months.
• Have self-reported menopause related joint outcomes of moderate or severe severity according to a perceived discomfort greater or equal to 5 and less than 10 on a scale of 0-10 (participants rating their discomfort 5-9 will be included).
• Have self-reported \> or equal to 4 hot flashes on average per day.
• In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
• Agree to refrain from treatments listed in Section 6.5 in the defined timeframe.
• Have reliable, stable access to Wi-Fi and a smart phone/device.

Exclusion criteria

• Individuals who are lactating, pregnant, or planning to become pregnant during the study.
• Active participation in a clinical trial.
• Use of any treatment for menopausal outcomes or other concomitant treatments for menopausal symptoms, joint health or at the discretion of the investigator. (Participants may be deemed ineligible at the discretion of the investigator if the medication may cause adverse interaction.)
• Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.
• Use of Glucosamine and/or Chondroitin for joint outcomes in the last 3 months prior to screening.
• Received a COVID-19 vaccine in the 2 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 3 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 (i.e., Lyme disease, TB, HIV).
• History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-05-14
• Primary completion: 2026-07
• Last update posted: 2025-11-20
• First posted: 2025-11-20

Sponsor & contact

Lead sponsor: Bonafide Health (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change from Baseline in Menopause Related Quality of Life Outcomes (From enrollment to the end of study at 12 weeks)
  Change from baseline in scores for severity of perceived joint discomfort, frequency of perceived joint discomfort, perceived joint mobility and perceived daily mobility assessed via a Visual Analog Scale (VAS). Response options will range from 0-100, with a higher score reflecting the worse outcome.
• Change from Baseline in Menopause Related Quality of Life Outcomes (From enrollment to the end of study at 12 weeks)
  Change from baseline in scores for Arthralgia Inventory (PRAI) score. The rating scale ranges from 0-10, with a higher score indicating a worse outcome.
• Change from Baseline in Menopause Related Quality of Life Outcomes (From enrollment to the end of study at 12 weeks)
  Change from baseline in scores for Musculoskeletal Health Questionnaire (MSK-HQ) score. Each response ranges from "not at all" to "very severe", with a higher score indicating a better outcome.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.