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NCT03963323 Clinical Trial

Glucosamine and Chondroitin in Gut in Preventing People From Inflammation

Healthy Subject Clinical Trial

Official title:
GLANCE2.1 - Glucosamine and Chondroitin (G&C) Effects Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03963323
Other study ID # RG1001759
Secondary ID 8645
Status Completed
Phase Phase 1
First received
Last updated
Start date May 11, 2018
Est. completion date March 31, 2019

Study information
Verified date May 2019
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies glucosamine and chondroitin in preventing inflammation. Glucosamine and chondroitin often used as a dietary supplement to promote joint health may have a preventive role in inflammation and cancer. This trial may help identify the bacteria that help process them in the gut.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria:

- From the Greater Seattle area

Exclusion Criteria:

- Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases)

- Pregnancy or lactation

- Currently on a weight-loss diet

- Alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits)

- Current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (IUD)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), or use of aspirin or NSAIDs more than 2 days per week

- Abnormal renal, liver or metabolic test

- Inability to swallow pills

- Known allergy to shellfish

- Not willing to take pills made from shellfish or animal sources

- Intention to relocate out of study area within next 2 months

- Any antibiotic use in the past 6 months

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Glucosamine Sulfate/Chondroitin Sulfate Tablet
Given PO
Other:
• Placebo
Given PO

Locations
Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants that experienced a shift in bacterial community assessed by operational taxonomic units Shifts in the bacterial communities is based on clustering of operational taxonomic units (OTU) at 97% similarity Up to 2 years
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