Product Responsiveness to Enhanced Bioavailability Curcumin Dietary Supplements in Adults
NCT ID: NCT07196046
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-21
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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A
Supplement order will vary based on randomization.
Supplement 2
A dietary supplement administered daily for 30 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
Supplement 3
A third dietary supplement administered daily for 30 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
Supplement 1
A dietary supplement administered daily for 14 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
B
Supplement order will vary based on randomization.
Supplement 2
A dietary supplement administered daily for 30 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
Supplement 3
A third dietary supplement administered daily for 30 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
Supplement 1
A dietary supplement administered daily for 14 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
Interventions
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Supplement 2
A dietary supplement administered daily for 30 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
Supplement 3
A third dietary supplement administered daily for 30 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
Supplement 1
A dietary supplement administered daily for 14 days. This supplement is being evaluated as part of a randomized, double-blind, crossover study to assess its effect on joint comfort. This product may be a placebo.
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
85 Years
ALL
No
Sponsors
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Ultra Botanica LLC
OTHER
Responsible Party
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Principal Investigators
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Adam Payne, CEO, MBA
Role: PRINCIPAL_INVESTIGATOR
Ultra Botanica LLC
Locations
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Ultra Botanica LLC
Oklahoma City, Oklahoma, United States
Countries
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Related Links
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MAPI Research Trust. (n.d.). Patient Global Impressions scale - Change, Improvement, Severity (PGI-C, PGI-I, PGI-S) (eProvide, Ed.) \[Review of Patient Global Impressions scale - Change, Improvement, Severity (PGI-C, PGI-I, PGI-S)\]
Pagare, V. (2011). Numeric Pain Rating Scale. Physiopedia.
Other Identifiers
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UBL-2024
Identifier Type: -
Identifier Source: org_study_id
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