Glucosamine and Chondroitin in Gut in Preventing People From Inflammation

NCT03963323 | Completed Phase 1

• 2 other identifiers: RG10017598645
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm I (glucosamine sulfate/chondroitin sulfate tablet)

EXPERIMENTAL

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

Arm II (placebo)

PLACEBO COMPARATOR

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

Interventions

Glucosamine Sulfate/Chondroitin Sulfate Tablet DIETARY_SUPPLEMENT

Given PO

Arm I (glucosamine sulfate/chondroitin sulfate tablet)

Placebo OTHER

Given PO

Also known as: PLCB, sham therapy

Arm II (placebo)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- From the Greater Seattle area

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Glucosamine; Chondroitin Sulfates

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Chondroitin; Glycosaminoglycans; Polysaccharides

Study Officials

• Joanna Lampe

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: May 11, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)