Phase
Condition
Rheumatoid Arthritis
Arthritis And Arthritic Pain (Pediatric)
Joint Injuries
Treatment
Placebo
JDS-HF3.0
Clinical Study ID
Ages 50-70 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 inindividuals 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 severityaccording to a perceived discomfort greater or equal to 5 and less than 10 on ascale 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 ableto 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.
Willing and able to agree to the requirements and restrictions of this study, bewilling to give voluntary consent, be able to understand and read questionnaires,and carry out all study-related procedures.
Exclusion
Exclusion Criteria:
Individuals who are lactating, pregnant, or planning to become pregnant during thestudy.
Active participation in a clinical trial.
Use of any treatment for menopausal outcomes or other concomitant treatments formenopausal symptoms, joint health or at the discretion of the investigator. (Participants may be deemed ineligible at the discretion of the investigator if themedication may cause adverse interaction.)
Have a known sensitivity, intolerability, or allergy to any of the study product ortheir excipients.
Use of Glucosamine and/or Chondroitin for joint outcomes in the last 3 months priorto screening.
Received a COVID-19 vaccine in the 2 weeks prior to screening or during the studyperiod, current COVID-19 infections or currently have the post-COVID-19 condition asdefined by World Health Organization (WHO) (i.e., individuals with a history ofprobable or confirmed SARS-CoV-2 infection, usually 3 months from the onset ofCOVID-19 with symptoms that last for at least two months and cannot be explained byan 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.
History of any clinically significant disease or disorder which, in the opinion ofthe investigator, may either put the potential subject at risk because ofparticipation in the study or influence the results or the potential subject'sability to participate in the study.
History or presence of gastrointestinal, hepatic, or renal disease, or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, gastricbypass procedures, or pancreatic insufficiency).
Participant has an abnormality or obstruction of the gastrointestinal tractprecluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinalmalabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis,steatorrhea).
Major surgery in three months prior to screening or planned major surgery during thestudy.
History of alcohol or substance abuse in the last 5 years.
Has evidence of inflammatory rheumatic disease or other diagnosed anti-inflammatorydisease.
Has evidence of autoimmune disease(s).
Chronic use of curcumin or curcuminoids in an herbal or dietary supplement. Note:Screened participants that are willing to undergo a washout period of at least 3months prior to participation in the trial can be enrolled.
Chronic pain medication and use of analgesics specifically for joint-relateddiscomfort (i.e. Opiates, Tramadol) Note: Screened participants that are willing toundergo a washout period of at least 2 weeks during the duration of the trial can beenrolled.
Have severe joint and/or severe bone deformities.
Diagnosed bone fractures.
Are a candidate for surgical joint replacement.
Study Design
Study Description
Connect with a study center
Bonafide Health
Harrison 5120095, New York 5128638 10528
United StatesActive - Recruiting

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