Glucosamine and Chondroitin in Gut in Preventing People From Inflammation

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Subject

Intervention / Treatment
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* Dietary Supplement: Glucosamine Sulfate/Chondroitin Sulfate Tablet
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (glucosamine sulfate/chondroitin sulfate tablet)<br>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. | Dietary Supplement: Glucosamine Sulfate/Chondroitin Sulfate Tablet<br>* Given PO<br>|
| Placebo Comparator: Arm II (placebo)<br>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. | Other: Placebo<br>* Given PO<br>* Other names: sham therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |