Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of JDS-HF3.0 in Menopause Related Quality of Life Outcomes in Postmenopausal Women
Bonafide Health
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.
Description
About 250 women across the U.S. will take part in this study. Participants will be randomly placed into one of two groups-one will take the active study product, and the other will take a placebo. All participants will take two tablets each morning for about 12 weeks. The total time the participant will be in the study is about 14 weeks, including the time it takes to collect baseline values. All parts of the study are done virtually, in-person visits are not required. The participant will take part in five virtual check-ins, including a screening visit, a baseline visit, two check-ins during…
Eligibility
- Age range
- 50–70 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Healthy biological females who are 50-70 years of age (inclusive). 2. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive). 3. 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. 4. 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…
Interventions
- Dietary SupplementJDS-HF3.0
Active Supplement JDS-HF3.0
- OtherPlacebo
Nonactive Placebo
Location
- Bonafide HealthHarrison, New York