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Trial record 1 of 1 for:    NCT01682694
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Glucosamine and Chondroitin Effects (GLANCE)

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ClinicalTrials.gov Identifier: NCT01682694
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

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

Condition or disease Intervention/treatment Phase
Inflammation Dietary Supplement: Glucosamine and Chondroitin Dietary Supplement: placebo Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Glucosamine and Chondroitin Effects
Study Start Date : September 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Glucosamine and Chondroitin
Glucosamine and Chondroitin
 Dietary Supplement: Glucosamine and Chondroitin
Glucosamine (1500 mg) and Chondroitin (1200 mg)
Other Name: Nutramax
Placebo Comparator: Placebo
Inactive ingredients
 Dietary Supplement: placebo


Outcome Measures
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Primary Outcome Measures :
  1. hsCRP [ Time Frame: 1 year ]
    hsCRP is a biomarker of systemic inflammation


Secondary Outcome Measures :
  1. untargeted (exploratory) serum metabolomics (differences in small molecule abundance ratios) [ Time Frame: 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682694


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT01682694    
Other Study ID Numbers: 7798
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes