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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:
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:
The study is conducted remotely using the Alethios decentralized research platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Supplement order will vary based on randomization. |
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| B | Experimental | Supplement order will vary based on randomization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement 2 | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Onboarding, Day 32, Day 69, Day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 2, Day 8, Day 15, Day 21, Day 29, Day 39, Day 46, Day 53, Day 58, Day 66, Day 69, Day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| Wearable-Derived Activity and Sleep Metrics | 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 | From eConsent to study completion; data collected before starting any intervention and then collected weekly |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Adam Payne, CEO, MBA | Ultra Botanica LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ultra Botanica LLC | Oklahoma City | Oklahoma | 73105 | United States |
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| Label | URL |
|---|---|
| MAPI Research Trust. (n.d.). Patient Global Impressions scale - Change, Improvement, Severity (PGI-C, PGI-I, PGI-S) (eProvide, Ed.) \[Review of Patient Global Impressions scale - Change, Improvement, Severity (PGI-C, PGI-I, PGI-S)\] | View source |
| Pagare, V. (2011). Numeric Pain Rating Scale. Physiopedia. | View source |
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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.
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| ID | Term |
|---|---|
| C000602145 | TARGET 1 dietary supplement |
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| Supplement 3 | Dietary 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. |
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| Supplement 1 | Dietary 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. |
|
| Pain and Discomfort Ratings (NRS) | Numeric Rating Scale (NRS) | 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) | Day 2 through Day 69 |
| Rescue Medication Use | Participant reports of rescue pain medication use (e.g., ibuprofen, acetaminophen), including frequency and perceived effectiveness | 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. | Day 8, Day 15, Day 21, Day 29, Day 46, Day 53, Day 58, Day 66 |
| End-of-Phase Supplement Reflections |
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 |
| Day 32 and Day 69 |