JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women (NCT07238478) | Clinical Trial Compass
RecruitingNot Applicable
JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women
United States250 participantsStarted 2025-05-14
Plain-language summary
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.
Who can participate
Age range50 Years – 70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
What they're measuring
1
Change from Baseline in Menopause Related Quality of Life Outcomes
Timeframe: From enrollment to the end of study at 12 weeks
2
Change from Baseline in Menopause Related Quality of Life Outcomes
Timeframe: From enrollment to the end of study at 12 weeks
3
Change from Baseline in Menopause Related Quality of Life Outcomes
Timeframe: From enrollment to the end of study at 12 weeks
✕. 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.