Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subject Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Glucosamine

Intervention Type DIETARY_SUPPLEMENT

Given PO

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Given PO

Interventions

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Glucosamine

Given PO

Intervention Type DIETARY_SUPPLEMENT

Placebo

Given PO

Intervention Type OTHER

Other Intervention Names

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PLCB

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes