Glucosamine and Chondroitin in Gut in Preventing People From Inflammation

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 1

Conditions: Healthy Subject

Treatments: Dietary Supplement: Glucosamine Sulfate/Chondroitin Sulfate Tablet; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03963323

RG1001759

8645 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 2 patient groups, including a placebo group

Arm I (glucosamine sulfate/chondroitin sulfate tablet)

Experimental group

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.

Treatment:

Dietary Supplement: Glucosamine Sulfate/Chondroitin Sulfate Tablet

Arm II (placebo)

Placebo Comparator group

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.

Treatment:

Other: Placebo