Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 1

Conditions: Healthy Subject; Overweight

Treatments: Other: Placebo; Dietary Supplement: Glucosamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03827161

NCI-2018-02647 (Other Identifier)

RG1001578

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 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

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