Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

Study Overview
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Brief Summary
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This trial studies glucosamine and chondroitin in preventing inflammation in overweight patients. Chronic inflammation contributes to cancer formation, and biomarkers of inflammation have been associated with cancer risk. Glucosamine and chondroitin may prevent inflammation and this trial may help identify the bacteria that help process them in the gut.

Official Title
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GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study

Conditions
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Healthy Subject, Overweight

Intervention / Treatment
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* Dietary Supplement: Glucosamine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Individuals from the Greater Seattle area who are overweight (body mass index [BMI] of 25-32.5 kg/m^2) 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 BMI (body mass index) < 25 or > 32.5 kg/m^2 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<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: PLCB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation | shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis [PCOA]). | Up to 2 years | 
| Effects of G&C on serum C-reactive protein (CRP) | evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual | Up to 2 years |