Glucosamine and Chondroitin Effects

Inflammation Clinical Trial

— GLANCE  

Official title:

Glucosamine and Chondroitin Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682694
• Other study ID #: 7798
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: May 23, 2014
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• Glucosamine and Chondroitin
Glucosamine (1500 mg) and Chondroitin (1200 mg)
• placebo

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hsCRP	hsCRP is a biomarker of systemic inflammation	1 year	No
Secondary	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	No