Interindividual Variation in Excretion of Curcumin

University of Massachusetts Amherst

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

Study Overview

• Status: Completed
• Conditions: Gut Microbiota; Metabolites
• Intervention / Treatment: Dietary supplement: curcumin

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • Institute for Applied Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (ACTUAL): November 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 2018-4937

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No