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NCT03746158 Clinical Trial

Interindividual Variation in Excretion of Curcumin

Gut Microbiota Clinical Trial

Official title:
University of Massachusetts Amherst

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03746158
Other study ID # 2018-4937
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date October 1, 2019

Study information
Verified date March 2020
Source University of Massachusetts, Amherst
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date October 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
United States Institute for Applied Life Sciences Amherst Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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