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Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

Primary Purpose

Healthy Subject, Overweight

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glucosamine
Placebo
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Subject

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (glucosamine sulfate/chondroitin sulfate tablet)

Arm II (placebo)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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]).
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

Secondary Outcome Measures

Full Information

First Posted
January 30, 2019
Last Updated
January 30, 2019
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03827161
Brief Title
Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients
Official Title
GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subject, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (glucosamine sulfate/chondroitin sulfate tablet)
Arm Type
Experimental
Arm Description
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 Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucosamine
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation
Description
shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis [PCOA]).
Time Frame
Up to 2 years
Title
Effects of G&C on serum C-reactive protein (CRP)
Description
evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna Lampe
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

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