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Glucosamine and Chondroitin Effects (GLANCE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01682694
First received: September 4, 2012
Last updated: June 6, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition Intervention
Inflammation
 Dietary Supplement: Glucosamine and Chondroitin
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Glucosamine and Chondroitin Effects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • hsCRP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    hsCRP is a biomarker of systemic inflammation


Secondary Outcome Measures:
  • untargeted (exploratory) serum metabolomics (differences in small molecule abundance ratios) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682694

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT01682694     History of Changes
Other Study ID Numbers: 7798
Study First Received: September 4, 2012
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013