Product Responsiveness to Enhanced Bioavailability Curcumin Dietary Supplements in Adults

A Randomized Double-Blind, Comparator-Controlled, Single-Site Study With a Single-Blind Placebo Run-In and Crossover Design to Evaluate Joint Comfort in Adults Using Enhanced Bioavailability Curcumin Dietary Supplements

The goal of this clinical trial is to evaluate whether distinct formulations of bioavailable curcumin supplements can improve joint comfort in adults who experience self-reported discomfort. Participants will also receive a placebo during the study, but they will not know when they receive it.

The main questions it aims to answer are:

• Do participants report improved joint comfort after taking each curcumin-based supplement?
• Are there difference in quality-of-life scores or pain perceptions between the products?

Researchers will compare the effects of the different formulations of bioavailable curcumin supplements to see if one provides greater improvements in joint comfort and related outcomes.

Participants will:

• Wear a fitness tracker starting at the time of electronic consent to provide continuous data on physical activity, heart rate, and sleep
• Complete multiple blinded study periods involving different oral supplements, each separated by a washout period
• Take one supplement twice daily during each intervention period, with intervention periods lasting between approximately two and four weeks
• Complete washout periods of approximately one week between intervention periods
• Complete the validated RAND-36 quality-of-life questionnaire and other study-specific questionnaires adapted from commonly used pain and global impression scales to assess joint comfort, pain perception, and overall health
• Participate in a 30-day follow up period after the final supplement to complete final questionnaires and wearable data collection

The study is conducted remotely using the Alethios decentralized research platform.

Inclusion Criteria

1. Able to provide a digital or wet signed informed consent to participate in the study
2. Willing and able to comply with all study requirements and instructions of the site study staff
3. Meets the study inclusionary criteria and voluntarily gives informed consent for participation
4. Male or female, 30 to 85 years old (inclusive)
5. Ambulatory without use of a walker or cane
6. Study participant must be symptomatic (self-professed, not diagnosed) for 6 months or longer
7. Occasional mild to moderate discomfort and/or pain of major or collection of minor joints defined by a level of 4-8 on screening NRS
8. No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).
9. Possession of a functional wearable device (e.g., Apple Watch, Fitbit, Garmin) compatible with the Alethios platform and willingness to link it to the platform for continuous data collection during the study period, and able to use the device for the study duration.

Exclusion Criteria

1. A history of allergic reactions to Dairy or Dairy proteins, Turmeric, or Curcumin
2. Any medical history of joint disease or pain syndrome interfering with evaluation of joint discomfort, such as rheumatoid arthritis, psoriatic arthritis, gout, aseptic necrosis, joint replacement, complex regional pain syndrome, fibromyalgia, peripheral neuropathy, or malignancy (left to Principal Investigator (PI) discretion)
3. Presence of significant medical, neurological, or psychiatric condition that could interfere with ambulation or self-assessment ability such as: unmanaged diabetes, uncontrolled hypertension, heart failure, Alzheimer's disease, Parkinson's disease, intracranial hemorrhage, multiple sclerosis, or traumatic brain injury (left to Principal Investigator (PI) discretion)
4. Liver, kidney, gallbladder, or peptic ulcer disease, or active disorders of the intestinal tract that may interfere with supplement absorption, distribution, or clearance.
5. Surgery, hospitalization, or fracture within the 6 months prior to screening.
6. Presence of discomfort and/or pain that in a self-professed description severely limits mobility.
7. Any pharmacological or non-pharmacological treatment targeting joint discomfort that was initiated or modified within 4 weeks prior to randomization
8. Prohibited Medications & Treatments - The following medications and treatments are not permitted during the study: a. Intra-articular (IA) injections of any kind; b. Blood thinners; c. Opioid-containing analgesics; d. Topical treatments targeting joint discomfort; e. Systemic medical treatments that may interfere with liver or kidney function or ambulation; f. Immunosuppressants; g. Corticosteroids exceeding 5 mg prednisone equivalent per day (If ≤5 mg prednisone, the dose must be stable for at least 6 months.); h. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen
9. Pregnant or breastfeeding individuals will be excluded from participation due to the lack of safety data on these formulations in these populations. Participants who become pregnant during the study must notify the study team immediately and will be withdrawn from the study.
10. As a result of the medical review and screening investigation, the Principal Investigator considers the study participant not suitable for the study due to limitations in self-assessment ability, difficulty with ambulation, conditions interfering with perception of joint discomfort, or conditions or medications that preclude safe use of supplement.