- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01682694
Glucosamine and Chondroitin Effects (GLANCE)
May 23, 2014 updated by: Fred Hutchinson Cancer Center
A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected by a reduction in serum C-reactive protein.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Glucosamine and Chondroitin
|
Glucosamine (1500 mg) and Chondroitin (1200 mg)
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Inactive ingredients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hsCRP
Time Frame: 1 year
|
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)
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
September 4, 2012
First Submitted That Met QC Criteria
September 10, 2012
First Posted (ESTIMATE)
September 11, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 28, 2014
Last Update Submitted That Met QC Criteria
May 23, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7798 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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