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Active Not RecruitingNCT07196046

Product Responsiveness to Enhanced Bioavailability Curcumin Dietary Supplements in Adults

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Ultra Botanica LLC · Academic / Other
Sex
All
Age
30 Years – 85 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTSupplement 2A 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.
DIETARY_SUPPLEMENTSupplement 3A 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.
DIETARY_SUPPLEMENTSupplement 1A 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.

Timeline

Start date
2025-12-10
Primary completion
2026-07-01
Completion
2026-08-01
First posted
2025-09-29
Last updated
2026-02-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07196046. Inclusion in this directory is not an endorsement.