InflammationNCT05349032
Assessing the Bioavailability of Leading Phytonutrient Products
A study testing Curcumin in people with Inflammation, run by Epiceutical Labs at 1 site in United States.
Trial summary
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. The study will secondarily look at inflammatory markers in the urine to determine any change. Read more about this study
- Who is it for?
- Ages 21 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age and gender
Who cannot join
- Cannot take any phytonutrient or curcumin supplement five days prior to commencement.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
David Roberts
Charlottesville, Virginia, 22902
David Roberts, MPH, 434-981-8629, droberts@brocelite.com
About this study
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. The study will secondarily look at inflammatory markers in the urine to determine any change.
Read the detailed description
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. 120 mg of curcumin from brands Meriva, CurcElite, Lonvida, UltraCur, NovaSol. The study will secondarily look at inflammatory markers in the urine to determine any change.
- Conditions
- Inflammation
- Being tested
- Curcumin
- Keywords
- infalmmation, bioavailability
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Oral supplement
| Study group | Role | What they receive |
|---|---|---|
| Meriva | Other | 120 mg of curcumin in Meriva. Receives: Dietary Supplement: Curcumin |
| Longvida | Other | 120 mg of curcumin Longvida. Receives: Dietary Supplement: Curcumin |
| NovaSol | Other | 120 mg of curcumin NovaSol Receives: Dietary Supplement: Curcumin |
| CurcElite | Other | 120 mg of curcumin CurcElite Receives: Dietary Supplement: Curcumin |
| UltaCur | Other | 120 mg of curcumin Ultracur Receives: Dietary Supplement: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability
Blood Plasma
Measured: 0, 1, 2, 4, and 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Mar 2022
- Primary completion30 Apr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epiceutical Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349032
- Sponsor's protocol ID
- 101
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Blood plasma and urine samples will be collected for five different times over five different supplements.
Publications
Jamwal R. Bioavailable curcumin formulations: A review of pharmacokinetic studies in healthy volunteers. J Integr Med. 2018 Nov;16(6):367-374. doi: 10.1016/j.joim.2018.07.001. Epub 2018 Jul 4.
PubMed 30006023
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Bioavailability of Leading Phytonutrient Products
- ClinicalTrials.gov ID
- NCT05349032
- Acronym / sponsor ID
- 101
- Conditions
- Inflammation
- Keywords
- infalmmation, bioavailability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Epiceutical LabsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. The study will secondarily look at inflammatory markers in the urine to determine any change.
Detailed description
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. 120 mg of curcumin from brands Meriva, CurcElite, Lonvida, UltraCur, NovaSol. The study will secondarily look at inflammatory markers in the urine to determine any change.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Meriva | Other | Dietary Supplement: Curcumin120 mg of curcumin in Meriva. |
| Longvida | Other | Dietary Supplement: Curcumin120 mg of curcumin Longvida. |
| NovaSol | Other | Dietary Supplement: Curcumin120 mg of curcumin NovaSol |
| CurcElite | Other | Dietary Supplement: Curcumin120 mg of curcumin CurcElite |
| UltaCur | Other | Dietary Supplement: Curcumin120 mg of curcumin Ultracur |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age and gender
Key exclusion criteria (1 listed)
- Cannot take any phytonutrient or curcumin supplement five days prior to commencement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminOral supplement | Dietary supplement | CurcElite, Longvida, Meriva, NovaSol, UltaCur |
Primary outcome
Bioavailability
Time frame: 0, 1, 2, 4, and 12 hours
Blood Plasma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Results publication: PubMed 30006023Jamwal R. Bioavailable curcumin formulations: A review of pharmacokinetic studies in healthy volunteers. J Integr Med. 2018 Nov;16(6):367-374. doi: 10.1016/j.joim.2018.07.001. Epub 2018 Jul 4.
- Individual participant dataSharing planned: Undecided. Blood plasma and urine samples will be collected for five different times over five different supplements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Inflammation, run by Epiceutical Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Roberts, MPH (810777687, research@epiceuticallabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability (time frame: 0, 1, 2, 4, and 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.