Glucosamine and Chondroitin Effects

Study Overview
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Brief Summary
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A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected by a reduction in serum C-reactive protein.

Detailed Description
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Use of glucosamine and chondroitin have been associated with reduced cancer and overall mortality. The aim of this study is to determine whether a common starting dose of glucosamine and chondroitin (1500 mg/d + 1200 mg/d, respectively) reduces systemic inflammation as reflected by a reduction in high sensitivity C-reactive protein.

Official Title
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Glucosamine and Chondroitin Effects

Conditions
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Inflammation

Intervention / Treatment
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* Dietary Supplement: Glucosamine and Chondroitin
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Overweight (body mass index kg/m2 (BMI) between 25 and 32.5) Non-smoking men and women Aged 20-55y 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 > 30 Alcohol intake of greater than 2 drinks/day Current use of prescription or over-the-counter medications, (Excluding oral contraceptives and hormone-secreting IUDs), including 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 4 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucosamine and Chondroitin<br>Glucosamine and Chondroitin | Dietary Supplement: Glucosamine and Chondroitin<br>* Glucosamine (1500 mg) and Chondroitin (1200 mg)<br>* Other names: Nutramax;|
| Placebo Comparator: Placebo<br>Inactive ingredients | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hsCRP | hsCRP is a biomarker of systemic inflammation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| untargeted (exploratory) serum metabolomics (differences in small molecule abundance ratios) | The mechanisms of action of glucosamine and chondroitin are currently unknown. Untargeted metabolomic assays of serum will be undertaken for exploratory analyses of potential effects of glucosamine and chondroitin. Significant differences in abundance ratios of small molecules between the intervention and placebo will be reported. | 1 year |