Glucosamine and Chondroitin in Gut in Preventing People From Inflammation

Phase 1

Completed

• Conditions: Healthy Subject
• Interventions: Dietary Supplement: Glucosamine Sulfate/Chondroitin Sulfate Tablet; Other: Placebo

• Registration Number: NCT03963323
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-11
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-05
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-24
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm I (glucosamine sulfate/chondroitin sulfate tablet)	Glucosamine Sulfate/Chondroitin Sulfate Tablet	Patients receive glucosamine sulfate/chondroitin sulfate tablet PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm II.
Arm II (placebo)	Placebo	Patients receive placebo PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm I.

Primary Outcome Measures

Name	Time	Method
Number of participants that experienced a shift in bacterial community assessed by operational taxonomic units	Up to 2 years	Shifts in the bacterial communities is based on clustering of operational taxonomic units (OTU) at 97% similarity

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States