Product Responsiveness to Enhanced Bioavailability Curcumin Dietary Supplements in Adults

Ultra Botanica LLC

Status: Active, not recruiting

Conditions: Quality of Life (QOL); Joint Discomfort

Treatments: Dietary Supplement: Supplement 3; Dietary Supplement: Supplement 2; Dietary Supplement: Supplement 1

Study type: Interventional

Funder types: Other

Identifiers

NCT07196046

UBL-2024

Details and patient eligibility

About

The goal of this clinical trial is to evaluate whether two 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 two products?

Researchers will compare the effects of two 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
• Take two supplements twice daily for 30 days, then complete a 7-day break (washout), followed by 30 days on the second supplement
• Take one supplement twice daily for 14 days then complete a 7-day break (washout)
• Complete validated questionnaires throughout the study to report on joint comfort, quality of life, 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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. Regular consumption of >7 standard alcoholic drinks/week where 1 standard drink is 0.6 fluid ounces of "pure" ethanol and is equivalent to 12 oz of beer (5% alc/vol), 5 oz wine (12% alc/vol), or 1.5 oz distilled spirits (40% alc/vol).
10. 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.
11. 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

A

Experimental group

Description:

Supplement order will vary based on randomization.

Treatment:

Dietary Supplement: Supplement 1

Dietary Supplement: Supplement 2

Dietary Supplement: Supplement 3

B

Experimental group

Description:

Supplement order will vary based on randomization.

Treatment:

Dietary Supplement: Supplement 1

Dietary Supplement: Supplement 2

Dietary Supplement: Supplement 3