Interindividual Variation in Excretion of Curcumin

Sponsor

University of Massachusetts, Amherst (Other)

Overall Status

Completed

CT.gov ID

NCT03746158

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metabolites Gut Microbiota	Dietary Supplement: curcumin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

University of Massachusetts Amherst

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Curcumin 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 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).

Arm

Intervention/Treatment

Experimental: Curcumin

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

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).

Outcome Measures

Primary Outcome Measures

Determine the concentration of curcumin and its metabolites in the human fecal samples. [3-4 weeks]
Utilize LC-MSMS to identify and quantify the curcumin and its metabolites in the subjects fecal samples.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-30 year old healthy adults

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Applied Life Sciences	Amherst	Massachusetts	United States	01003

Sponsors and Collaborators

University of Massachusetts, Amherst

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Massachusetts, Amherst

ClinicalTrials.gov Identifier:

NCT03746158

Other Study ID Numbers:

2018-4937

First Posted:

Nov 19, 2018

Last Update Posted:

Dec 17, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Curcumin

Study Results

No Results Posted as of Dec 17, 2020