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OpenTrials
Completed

NCT Number: NCT03827161

Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

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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Key information

Conditions

Healthy Subject Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucosamine

Dietary Supplement

Given PO

Placebo

Other

Given PO

Other names: PLCB

Primary outcomes

  1. Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation

    Time frame: Up to 2 years

    shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis [PCOA]).

  2. Effects of G&C on serum C-reactive protein (CRP)

    Time frame: Up to 2 years

    evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2019
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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