NCT01682694

Brief Summary

A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected by a reduction in serum C-reactive protein.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

September 4, 2012

Last Update Submit

May 23, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • hsCRP

    hsCRP is a biomarker of systemic inflammation

    1 year

Secondary Outcomes (1)

  • untargeted (exploratory) serum metabolomics (differences in small molecule abundance ratios)

    1 year

Study Arms (2)

Glucosamine and Chondroitin

EXPERIMENTAL

Glucosamine and Chondroitin

Dietary Supplement: Glucosamine and Chondroitin

Placebo

PLACEBO COMPARATOR

Inactive ingredients

Dietary Supplement: placebo

Interventions

Glucosamine and ChondroitinDIETARY_SUPPLEMENT

Glucosamine (1500 mg) and Chondroitin (1200 mg)

Also known as: Nutramax
Glucosamine and Chondroitin
placeboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Overweight (body mass index kg/m2 (BMI) between 25 and 32.5)
  • Non-smoking men and women
  • Aged 20-55y

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
  • BMI (body mass index) \< 25 or \> 30
  • Alcohol intake of greater than 2 drinks/day
  • Current use of prescription or over-the-counter medications, (Excluding oral contraceptives and hormone-secreting IUDs), including 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 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Navarro SL, White E, Kantor ED, Zhang Y, Rho J, Song X, Milne GL, Lampe PD, Lampe JW. Randomized trial of glucosamine and chondroitin supplementation on inflammation and oxidative stress biomarkers and plasma proteomics profiles in healthy humans. PLoS One. 2015 Feb 26;10(2):e0117534. doi: 10.1371/journal.pone.0117534. eCollection 2015.

MeSH Terms

Conditions

Inflammation

Interventions

GlucosamineChondroitin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydratesGlycosaminoglycansPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 11, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations