Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

Phase 1

Completed

• Conditions: Healthy Subject; Overweight
• Interventions: Dietary Supplement: Glucosamine; Other: Placebo

• Registration Number: NCT03827161
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-02-01
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm I (glucosamine sulfate/chondroitin sulfate tablet)	Glucosamine	Patients receive glucosamine sulfate/chondroitin sulfate tablet PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm II.
Arm II (placebo)	Placebo	Patients receive placebo PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm I.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States