Ultra Botanica LLC
Oklahoma City, Oklahoma, 73105, United States
NCT Number: NCT07196046
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.
This study is active but is not currently recruiting participants.
30 year–85 year
All sexes
Interventional
Not applicable
Oklahoma City, Oklahoma, 73105, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Onboarding, Day 32, Day 69, Day 98
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.
Time frame: Day 2, Day 8, Day 15, Day 21, Day 29, Day 39, Day 46, Day 53, Day 58, Day 66, Day 69, Day 98
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.
Time frame: Day 2, Day 8, Day 15, Day 21, Day 29, Day 39, Day 46, Day 53, Day 58, Day 66, Day 69, Day 98
Numeric Rating Scale (NRS)
Time frame: Day 2 through Day 69
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)
Time frame: Day 8, Day 15, Day 21, Day 29, Day 46, Day 53, Day 58, Day 66
Participant reports of rescue pain medication use (e.g., ibuprofen, acetaminophen), including frequency and perceived effectiveness
Time frame: Day 8, Day 15, Day 21, Day 29, Day 46, Day 53, Day 58, Day 66
Self-reported adherence to the prescribed supplement intake schedule. Includes reasons for missed doses.
Time frame: From eConsent to study completion; data collected before starting any intervention and then collected weekly
Continuous collection of step count, heart rate variability, and sleep duration using a wearable device. Used for exploratory correlations with self-reported comfort and quality-of-life outcomes
Time frame: Day 32 and Day 69
Participant summaries of their experiences during each supplement phase, including joint comfort, mobility, and alignment with expectations. Includes multiple-choice and optional open-text responses
Ultra Botanica LLC
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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