MetabolitesNCT03746158
Interindividual Variation in Excretion of Curcumin
A study testing curcumin in people with Metabolites and Gut Microbiota, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
The objective of this project is to elucidate the interindividual variations in excretion of curcumin and its metabolites. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolites, Gut Microbiota
- 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Oct 2019
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 year old healthy adults
Who cannot join
- Exclusion criteria included those who are <18 or >30 years old, have a BMI of <20 or >29 kg/m2, have a weight change >4.5 kg in the past 3 months, exceed exercise activities of a curcumin level over the past 3 months, have any diseases, especially intestinal disorders, had abnormal liver or kidney function tests. Those who smoke, consume more than two alcoholic drinks per day, use medication affecting gut microbiota profile (e.g., antibiotics and probiotics) in past three months will also be excluded.
- Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Applied Life Sciences
Amherst, Massachusetts, 01003
About this study
Official title: University of Massachusetts Amherst
The objective of this project is to elucidate the interindividual variations in excretion of curcumin and its metabolites.
- Conditions
- Metabolites, Gut Microbiota
- Being tested
- curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDietary supplement
subjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal).
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | subjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal). Receives: Dietary Supplement: curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the concentration of curcumin and its metabolites in the human fecal samples.
Utilize LC-MSMS to identify and quantify the curcumin and its metabolites in the subjects fecal samples.
Measured: 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Sep 2018
- Primary completion1 Mar 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolitesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746158
- Sponsor's protocol ID
- 2018-4937
- Status last verified
- Mar 2020
- First submitted
- 15 Nov 2018
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Massachusetts Amherst
- ClinicalTrials.gov ID
- NCT03746158
- Acronym / sponsor ID
- 2018-4937
- Conditions
- Metabolites, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 19 Nov 2018 (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 objective of this project is to elucidate the interindividual variations in excretion of curcumin and its metabolites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Dietary Supplement: curcuminsubjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-30 year old healthy adults
Key exclusion criteria (2 listed)
- Exclusion criteria included those who are <18 or >30 years old, have a BMI of <20 or >29 kg/m2, have a weight change >4.5 kg in the past 3 months, exceed exercise activities of a curcumin level over the past 3 months, have any diseases, especially intestinal disorders, had abnormal liver or kidney function tests. Those who smoke, consume more than two alcoholic drinks per day, use medication affecting gut microbiota profile (e.g., antibiotics and probiotics) in past three months will also be excluded.
- Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.
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 |
|---|---|---|
| curcuminsubjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal). | Dietary supplement | Curcumin |
Primary outcome
Determine the concentration of curcumin and its metabolites in the human fecal samples.
Time frame: 3-4 weeks
Utilize LC-MSMS to identify and quantify the curcumin and its metabolites in the subjects fecal samples.
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 17 Dec 2020.
Related trials for Metabolites
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metabolites and Gut Microbiota, run by University of Massachusetts, Amherst 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 2 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 17 Dec 2020. 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?
Determine the concentration of curcumin and its metabolites in the human fecal samples. (time frame: 3-4 weeks). 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 17 Dec 2020.