Joint DiscomfortNCT07196046
Product Responsiveness to Enhanced Bioavailability Curcumin Dietary Supplements in Adults
A study testing Supplement 2, Supplement 3 and Supplement 1 in people with Joint Discomfort and Quality of Life (QOL), run by Ultra Botanica LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Joint Discomfort, Quality of Life (QOL)
- What is being tested?
- Supplement 2, Supplement 3 and Supplement 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide a digital or wet signed informed consent to participate in the study
- Willing and able to comply with all study requirements and instructions of the site study staff
- Meets the study inclusionary criteria and voluntarily gives informed consent for participation
- Male or female, 30 to 85 years old (inclusive)
- Ambulatory without use of a walker or cane
- Study participant must be symptomatic (self-professed, not diagnosed) for 6 months or longer
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- 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
- No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).
- 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.
Who cannot join
- A history of allergic reactions to Dairy or Dairy proteins, Turmeric, or Curcumin
- 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)
- 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)
- Liver, kidney, gallbladder, or peptic ulcer disease, or active disorders of the intestinal tract that may interfere with supplement absorption, distribution, or clearance.
- Surgery, hospitalization, or fracture within the 6 months prior to screening.
- Presence of discomfort and/or pain that in a self-professed description severely limits mobility.
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- Any pharmacological or non-pharmacological treatment targeting joint discomfort that was initiated or modified within 4 weeks prior to randomization
- 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
- 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.
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Joint Discomfort, Quality of Life (QOL)
- Being tested
- Supplement 2, Supplement 3, Supplement 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement 2Dietary supplement
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 3Dietary supplement
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 1Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Supplement order will vary based on randomization. Receives: Dietary Supplement: Supplement 2; Dietary Supplement: Supplement 3; Dietary Supplement: Supplement 1 |
| B | Experimental | Supplement order will vary based on randomization. Receives: Dietary Supplement: Supplement 2; Dietary Supplement: Supplement 3; Dietary Supplement: Supplement 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality-of-Life Scores (RAND-36)
Change in RAND-36 scores across the eight domains (physical functioning, role limitations, pain, general health, vitality, social functioning, emotional well-being, and mental health). Scores will be compared within and across supplement phases to evaluate participant-perceived quality of life.
Measured: Onboarding, Day 32, Day 69, Day 98
Secondary outcomes (5)
Self-Reported Joint Comfort (PGI-Style Scales)
Participant-reported changes in joint comfort and general well-being using PGI-style scales. Instruments ask participants to compare their current experience to baseline using a 7-point global impression scale.
Measured: Day 2, Day 8, Day 15, Day 21, Day 29, Day 39, Day 46, Day 53, Day 58, Day 66, Day 69, Day 98
Pain and Discomfort Ratings (NRS)
Numeric Rating Scale (NRS)
Measured: Day 2, Day 8, Day 15, Day 21, Day 29, Day 39, Day 46, Day 53, Day 58, Day 66, Day 69, Day 98
Timing of Perceived Impact
Participant-reported timing of initial improvement in joint comfort following the start of each supplement phase. Captured through structured response options (e.g., within hours, day)
Measured: Day 2 through Day 69
Rescue Medication Use
Participant reports of rescue pain medication use (e.g., ibuprofen, acetaminophen), including frequency and perceived effectiveness
Measured: Day 8, Day 15, Day 21, Day 29, Day 46, Day 53, Day 58, Day 66
Supplement Compliance
Self-reported adherence to the prescribed supplement intake schedule. Includes reasons for missed doses.
Measured: Day 8, Day 15, Day 21, Day 29, Day 46, Day 53, Day 58, Day 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start10 Dec 2025
- Primary completion19 Sep 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ultra Botanica LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Payne, CEO, MBA, Principal investigator, Ultra Botanica LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196046
- Sponsor's protocol ID
- UBL-2024
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Sponsor has not yet determined whether individual participant data (IPD) from this study will be shared. Given the small sample size and potential risk of re-identification, a decision will be made after study completion and data analysis.