Glucosamine and Chondroitin in Gut in Preventing People From Inflammation

GLANCE2.1 - Glucosamine and Chondroitin (G&C) Effects Study

This trial studies glucosamine and chondroitin in preventing inflammation. Glucosamine and chondroitin often used as a dietary supplement to promote joint health may have a preventive role in inflammation and cancer. This trial may help identify the bacteria that help process them in the gut.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Other: Placebo; Dietary supplement: Glucosamine Sulfate/Chondroitin Sulfate Tablet

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- From the Greater Seattle area

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
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Sulfate/Chondroitin Sulfate Tablet; 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 Names: PLCB; sham therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that experienced a shift in bacterial community assessed by operational taxonomic units	Shifts in the bacterial communities is based on clustering of operational taxonomic units (OTU) at 97% similarity	Up to 2 years

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Joanna Lampe, Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2018
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (ACTUAL): May 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RG1001759; 8645 (OTHER: FHCRC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No