HealthyCRCNCT03289507
Longvida Curcumin Human Pharmacokinetics Study
A study testing Treatment1, Treatment2 and Treatment3 in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The primary objective of the study is to characterize the curcumin metabolites of 2 different capsule formulations of curcumin relative to unformulated Curcuma longa extract of Rhizomes including assessing relative bioavailability and absorption/kinetic profile of curcumonoids and their metabolites in human plasma and… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment1, Treatment2 and Treatment3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2017to 30 Jan 2018
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Men or women, 20-45 years of age with body mass index (BMI) in range from 18.5 to 24.9 kg/m2
- Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 2 years)
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease that may interfere with study outcomes
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, gastrointestinal medications, antibiotics, anti-inflammatory drugs, dietary supplements including fiber supplements, prebiotics and probiotics, etc.
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, blood and urine sample collection procedures and study visit schedule)
- Minimum weight of 45 kg
Who cannot join
- Men and women who smoke
- Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations > 125 mg/dL
- Men and women who have uncontrolled blood pressure >160 mmHg (systolic) or 100 mmHg (diastolic)
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
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- Men and women with cancer other than non-melanoma skin cancer in previous 5 years
- Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
- Women who are known to be pregnant (pregnancy test will be completed for female subjects) or who are intending to become pregnant over the course of the study
- Women who are lactating
- Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
- Men and women who has participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
- Men and women who have donated blood within 3 months of the Screening Visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Men and women who are vegans
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
- Substance (alcohol or drug) abuse within the last 2 years
- Excessive coffee and tea consumers (> 5 cups/day)
- Men and women who do excessive exercise regularly or athlete
- Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
- Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
- Unusual working hours i.e., working overnight (e.g. 3rd shift)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Longvida Curcumin Human Pharmacokinetics (PK) Study
The primary objective of the study is to characterize the curcumin metabolites of 2 different capsule formulations of curcumin relative to unformulated Curcuma longa extract of Rhizomes including assessing relative bioavailability and absorption/kinetic profile of curcumonoids and their metabolites in human plasma and urine after acute consumption.
Read the detailed description
This study is a randomized, 3-arm, double-blinded, within subject cross-over trial focused on understanding pharmacokinetic profile of curcuminoids and their metabolites after intake of curcumin supplement with different capsule formulations.
A planned sample size of 6 will be enrolled into the study. This study will require one initial screening visit and 3 weekly visits. This study will take approximately 4 weeks per subject to complete.
The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.
If willing and eligible to participate, subjects will be invited to participate in the study for 3 study days. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration.
Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive a curcumin supplement based on randomized treatment sequences for 3 study visits immediately after fasting blood draw. The sequences of receiving the supplement at each visit will be randomly assigned based on treatment sequences.
Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5, 1, 2, 4, 6, and 8 hour (h) for assessment of change in plasma curcuminoids and metabolites. A standard breakfast will be provided immediately after the 0.5 h blood collection and standard lunch after 6 h blood collection. Urine samples will be collected at 0 (fasting), 4 and 8 h.
- Conditions
- Healthy
- Being tested
- Treatment1, Treatment2, Treatment3
- Keywords
- Longvida Curcumin, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment1Dietary supplement
Longvida Capsule formulation A
Treatment2Dietary supplement
Longvida Capsule formulation B
Treatment3Dietary supplement
Curcuma longa extract of Rhizomes
| Study group | Role | What they receive |
|---|---|---|
| Treatment1 | Active comparator | Longvida Capsule formulation A Receives: Dietary Supplement: Treatment1 |
| Treatment 2 | Active comparator | Longvida Capsule formulation B Receives: Dietary Supplement: Treatment2 |
| Treatment3 | Experimental | Curcuma longa extract of Rhizomes Receives: Dietary Supplement: Treatment3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma curcumin metabolites among 3 different treatments
Differences in plasma metabolites among 3 treatments
Measured: 8 hours Postprandial Study
Secondary outcomes (1)
Changes in urine metabolites among 3 different treatments
Differences in urine metabolites among 3 treatments
Measured: 8 hours Postprandial Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start19 Sep 2017
- Primary completion30 Nov 2017
- Study completion30 Jan 2018
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Verdure Sciences
- Responsible party
- Sponsor
- Investigators
- Britt M Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289507
- Sponsor's protocol ID
- IRB2017-086
- Acronym
- CRC
- Status last verified
- Feb 2023
- First submitted
- 14 Sep 2017
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longvida Curcumin Human Pharmacokinetics (PK) Study
- ClinicalTrials.gov ID
- NCT03289507
- Acronym / sponsor ID
- CRC / IRB2017-086
- Conditions
- Healthy
- Keywords
- Longvida Curcumin, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Verdure Sciences
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 21 Sep 2017 (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.
The primary objective of the study is to characterize the curcumin metabolites of 2 different capsule formulations of curcumin relative to unformulated Curcuma longa extract of Rhizomes including assessing relative bioavailability and absorption/kinetic profile of curcumonoids and their metabolites in human plasma and urine after acute consumption.
Detailed description
This study is a randomized, 3-arm, double-blinded, within subject cross-over trial focused on understanding pharmacokinetic profile of curcuminoids and their metabolites after intake of curcumin supplement with different capsule formulations.
A planned sample size of 6 will be enrolled into the study. This study will require one initial screening visit and 3 weekly visits. This study will take approximately 4 weeks per subject to complete.
The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.
If willing and eligible to participate, subjects will be invited to participate in the study for 3 study days. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration.
Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive a curcumin supplement based on randomized treatment sequences for 3 study visits immediately after fasting blood draw. The sequences of receiving the supplement at each visit will be randomly assigned based on treatment sequences.
Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5, 1, 2, 4, 6, and 8 hour (h) for assessment of change in plasma curcuminoids and metabolites. A standard breakfast will be provided immediately after the 0.5 h blood collection and standard lunch after 6 h blood collection. Urine samples will be collected at 0 (fasting), 4 and 8 h.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment1 | Active comparator | Dietary Supplement: Treatment1Longvida Capsule formulation A |
| Treatment 2 | Active comparator | Dietary Supplement: Treatment2Longvida Capsule formulation B |
| Treatment3 | Experimental | Dietary Supplement: Treatment3Curcuma longa extract of Rhizomes |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Men or women, 20-45 years of age with body mass index (BMI) in range from 18.5 to 24.9 kg/m2
Key exclusion criteria (21 listed)
- Men and women who smoke
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 |
|---|---|---|
| Treatment1Longvida Capsule formulation A | Dietary supplement | Treatment1 |
| Treatment2Longvida Capsule formulation B | Dietary supplement | Treatment 2 |
| Treatment3Curcuma longa extract of Rhizomes | Dietary supplement | Treatment3 |
Primary outcome
Changes in plasma curcumin metabolites among 3 different treatments
Time frame: 8 hours Postprandial Study
Differences in plasma metabolites among 3 treatments
1 secondary outcome
Changes in urine metabolites among 3 different treatments
Time frame: 8 hours Postprandial Study
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 8 Feb 2023.
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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.
Britt M Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment1, Treatment2 and Treatment3 in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 7 inclusion and 21 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 8 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 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?
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?
Changes in plasma curcumin metabolites among 3 different treatments (time frame: 8 hours Postprandial Study). 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 8 Feb 2023.