NCT03746158

Brief Summary

The objective of this project is to elucidate the interindividual variations in excretion of curcumin and its metabolites.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

December 17, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

November 15, 2018

Last Update Submit

December 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3-4 weeks

Study Arms (1)

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).

Dietary Supplement: curcumin

Interventions

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).

Curcumin

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old healthy adults

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Applied Life Sciences

Amherst, Massachusetts, 01003, United States

Location

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

September 1, 2018

Primary Completion

March 1, 2019

Study Completion

October 1, 2019

Last Updated

December 17, 2020

Record last verified: 2020-03

Locations