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Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827161
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research 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.

Condition or disease Intervention/treatment Phase
Healthy Subject Overweight Dietary Supplement: Glucosamine Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (glucosamine sulfate/chondroitin sulfate tablet)
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.
Dietary Supplement: Glucosamine
Given PO

Placebo Comparator: Arm II (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.
Other: Placebo
Given PO
Other Name: PLCB




Primary Outcome Measures :
  1. Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation [ Time Frame: 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]).

  2. Effects of G&C on serum C-reactive protein (CRP) [ Time Frame: Up to 2 years ]
    evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827161


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
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Principal Investigator: Johanna Lampe Fred Hutchinson Cancer Research Center
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03827161    
Other Study ID Numbers: RG1001578
NCI-2018-02647 ( Other Identifier: CTRP )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms