Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

Overweight Clinical Trial

Official title:

GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827161
• Other study ID #: RG1001578
• Secondary ID: NCI-2018-02647
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies glucosamine and chondroitin in preventing inflammation in overweight patients. Chronic inflammation contributes to cancer formation, and biomarkers of inflammation have been associated with cancer risk. Glucosamine and chondroitin may prevent inflammation and this trial may help identify the bacteria that help process them in the gut.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

-Individuals from the Greater Seattle area who are overweight (body mass index [BMI] of 25-32.5 kg/m^2)

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 > 32.5 kg/m^2

• Alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits)

• Current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (IUD)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), or 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 2 months

• Any antibiotic use in the past 6 months

Related Conditions & MeSH terms

• Healthy Subject
• Overweight

Intervention

Dietary Supplement:
• Glucosamine
Given PO

Other:
• Placebo
Given PO

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	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	Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation	shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis [PCOA]).	Up to 2 years
Primary	Effects of G&C on serum C-reactive protein (CRP)	evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual	Up to 2 years