HealthyNCT05535231
A Study to Evaluate the Effect of Turmeric in Healthy Participants
A study testing Turmeric test product and Turmeric comparator in people with Healthy, run by Gaia Herbs Inc. at 1 site in Canada.
Trial summary
Turmeric is recognized as a bioactive compound with potential benefits for human health. This study compares the pharmacokinetic profile of the Turmeric test product to a comparator. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Turmeric test product and Turmeric comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 24 Sep 2022to 3 Oct 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult participants who are 18 to 49 years of age (inclusive).
- In good general health (no active or uncontrolled diseases or conditions) and is able to consume the study product.
- Have a body mass index between 18.5 to 24.9 kg/m2 (inclusive).
- Have normal or acceptable to the investigator heart rate at screening.
- Individuals with childbearing potential should have a negative pregnancy test at baseline and must agree to practice an acceptable form of non-hormonal birth control throughout the study, including but not limited to:
- double-barrier method
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- non-hormonal intrauterine devices
- complete abstinence from sexual intercourse that can result in pregnancy
- vasectomy of partner at least 6 months prior to the first dose of study product Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable.
- Must have suitable veins for repeated venipuncture.
- Able to swallow pills or capsules whole and without chewing.
- Willing and able to comply with the protocol, including:
- Agrees to consume the standardized meals provided at the site during Visit 2 and Visit 3
- Agrees to fast overnight, i.e., no food or liquids for a minimum of 10 hours prior to dosing (except for water, permitted up to 1-hour prior to dosing) on Visit 2 and Visit 3
- Agrees to refrain from consuming grapefruit, pomelo, Seville orange, and starfruit containing foods/beverages 7 days prior to Visit 2 and throughout the study
- Agrees to refrain from caffeine/xanthine and alcohol or alcohol-containing products 48 hours prior to dosing on Visit 2 and Visit 3
- Agrees to refrain from the use/application of treatments/procedures listed in the protocol
- Agrees to maintain the same diet and exercise habits throughout the study
- Agrees not to donate blood or plasma for 30 days after completing the study
- Able to give voluntary consent
Who cannot join
- Participants who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the standardized study meals/snacks, study products or their excipients.
- Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis). Note: screened participants who have received a COVID-19 vaccine 2 weeks prior to screening would be eligible to participate after completing a 14-day washout period.
- Have uncontrolled or controlled high blood pressure (≥140 systolic or ≥90 diastolic mmHg) at screening.
- Have a history of heart disease/cardiovascular disease, renal or hepatic impairment/disease, diabetes (Type I or Type II), previously diagnosed or current diagnosis of any psychiatric disorders, unstable thyroid disease, immune disorders and/or immunocompromised (e.g. HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit, or any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the results or the potential participant's ability to participate in the study.
- Major surgery with general anesthesia in the 3 months prior to screening or planned major surgery during the course of the study.
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- Have a history of blood clotting disorders.
- Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to the first pharmacokinetic visit or a blood donation of more than 450 mL within 56 days prior to the first pharmacokinetic visit.
- Reports donating plasma (e.g., plasmapheresis) within 15 days prior to the first pharmacokinetic visit.
- Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
- Have gallstones, bile duct obstruction, stomach ulcers, excess stomach acid, or gastroesophageal reflux disease.
- History of alcohol or substance abuse in the 12 months prior to screening or use that to the opinion of the Qualified Investigator may be of a concern for the study.
- Receipt or use of test product(s) in another research study within 28 days prior to baseline or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Comparator-Controlled, Crossover Study to Evaluate the Pharmacokinetics of Gaia Full-Spectrum Turmeric Phytocapsules
Turmeric is recognized as a bioactive compound with potential benefits for human health. This study compares the pharmacokinetic profile of the Turmeric test product to a comparator.
Read the detailed description
This randomized, double-blinded, comparator-controlled, crossover study will compare the pharmacokinetic profile of the Turmeric test product to a comparator.
- Conditions
- Healthy
- Being tested
- Turmeric test product, Turmeric comparator
- Keywords
- Turmeric, Curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turmeric test productDietary supplement
Also called Turmeric Supreme Extra Strength
2 capsules of 490 mg Turmeric are taken with water once
Turmeric comparatorDietary supplement
Also called Renew Actives Turmeric Curcumin
2 capsules of 200 mg Turmeric are taken with water once
| Study group | Role | What they receive |
|---|---|---|
| Turmeric test product | Experimental | Turmeric Receives: Dietary Supplement: Turmeric test product |
| Turmeric comparator | Active comparator | Turmeric Receives: Dietary Supplement: Turmeric comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics- Area under the plasma concentration-time curve for 8 hours (AUC0-8h)
Test products area under the plasma concentration-time curve for 8 hours (AUC0-8h)
Measured: 8 hours
Pharmacokinetics- Peak plasma concentration (Cmax)
Test products Peak plasma concentration (Cmax)
Measured: 8 hours
Pharmacokinetics- Time to reach Cmax (Tmax)
Test products Time to reach Cmax (Tmax)
Measured: 8 hours
Secondary outcomes (5)
Pharmacokinetics- Total area under the curve (observed from 0-8 hours, and extrapolated from 8 hours to infinity) [AUC(0-∞)]
Test products Total area under the curve (observed from 0-8 hours, and extrapolated from 8 hours to infinity) [AUC(0-∞)]
Measured: 8 hours
Pharmacokinetics- Half-life (T1/2)
Test products Half-life (T1/2)
Measured: 8 hours
Pharmacokinetics- Terminal elimination rate constant (Kel)
Test products Terminal elimination rate constant (Kel)
Measured: 8 hours
Safety- participants experiencing adverse events
The number of participants experiencing Treatment Emergent Adverse Events (TEAEs)
Measured: 8 days
Safety- adverse events
The total number Treatment Emergent Adverse Events (TEAEs)
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start24 Sep 2022
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomization at 1:1 ratio for test product or comparator
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia Herbs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Anthony Bier, MD, Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535231
- Sponsor's protocol ID
- G02-21-01-T0030
- Status last verified
- Feb 2023
- First submitted
- 6 Sep 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Comparator-Controlled, Crossover Study to Evaluate the Pharmacokinetics of Gaia Full-Spectrum Turmeric Phytocapsules
- ClinicalTrials.gov ID
- NCT05535231
- Acronym / sponsor ID
- G02-21-01-T0030
- Conditions
- Healthy
- Keywords
- Turmeric, Curcumin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Gaia Herbs Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 24 Sep 2022 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 10 Sep 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.
Turmeric is recognized as a bioactive compound with potential benefits for human health. This study compares the pharmacokinetic profile of the Turmeric test product to a comparator.
Detailed description
This randomized, double-blinded, comparator-controlled, crossover study will compare the pharmacokinetic profile of the Turmeric test product to a comparator.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization at 1:1 ratio for test product or comparator
| Arm | Type | Receives |
|---|---|---|
| Turmeric test product | Experimental | Dietary Supplement: Turmeric test productTurmeric |
| Turmeric comparator | Active comparator | Dietary Supplement: Turmeric comparatorTurmeric |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Healthy adult participants who are 18 to 49 years of age (inclusive).
- In good general health (no active or uncontrolled diseases or conditions) and is able to consume the study product.
- Have a body mass index between 18.5 to 24.9 kg/m2 (inclusive).
- Have normal or acceptable to the investigator heart rate at screening.
- Individuals with childbearing potential should have a negative pregnancy test at baseline and must agree to practice an acceptable form of non-hormonal birth control throughout the study, including but not limited to:
Key exclusion criteria (14 listed)
- Participants who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the standardized study meals/snacks, study products or their excipients.
- Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis). Note: screened participants who have received a COVID-19 vaccine 2 weeks prior to screening would be eligible to participate after completing a 14-day washout period.
- Have uncontrolled or controlled high blood pressure (≥140 systolic or ≥90 diastolic mmHg) at screening.
- Have a history of heart disease/cardiovascular disease, renal or hepatic impairment/disease, diabetes (Type I or Type II), previously diagnosed or current diagnosis of any psychiatric disorders, unstable thyroid disease, immune disorders and/or immunocompromised (e.g. HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit, or any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the results or the potential participant's ability to participate in the study.
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 |
|---|---|---|
| Turmeric test productAlso: Turmeric Supreme Extra Strength2 capsules of 490 mg Turmeric are taken with water once | Dietary supplement | Turmeric test product |
| Turmeric comparatorAlso: Renew Actives Turmeric Curcumin2 capsules of 200 mg Turmeric are taken with water once | Dietary supplement | Turmeric comparator |
Primary outcome
Pharmacokinetics- Area under the plasma concentration-time curve for 8 hours (AUC0-8h)
Time frame: 8 hours
Test products area under the plasma concentration-time curve for 8 hours (AUC0-8h)
Pharmacokinetics- Peak plasma concentration (Cmax)
Time frame: 8 hours
Test products Peak plasma concentration (Cmax)
Pharmacokinetics- Time to reach Cmax (Tmax)
Time frame: 8 hours
Test products Time to reach Cmax (Tmax)
5 secondary outcomes
Pharmacokinetics- Total area under the curve (observed from 0-8 hours, and extrapolated from 8 hours to infinity) [AUC(0-∞)]
Time frame: 8 hours
Pharmacokinetics- Half-life (T1/2)
Time frame: 8 hours
Pharmacokinetics- Terminal elimination rate constant (Kel)
Time frame: 8 hours
Safety- participants experiencing adverse events
Time frame: 8 days
Safety- adverse events
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Anthony Bier, MD principal investigator
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turmeric test product and Turmeric comparator in people with Healthy, run by Gaia Herbs Inc. at 1 site in Canada.
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 20 inclusion and 14 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: finished, as of the sponsor's last update on 24 Feb 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics- Area under the plasma concentration-time curve for 8 hours (AUC0-8h) (time frame: 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2023.