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ENDOCUR - Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults (ENDOCUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03329781
Recruitment Status : Unknown
Verified October 2017 by Emilie Combet, University of Glasgow.
Recruitment status was:  Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Emilie Combet, University of Glasgow

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 6, 2017
Actual Study Start Date  ICMJE February 2015
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Level of endotoxin in plasma. [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ENDOCUR - Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
Official Title  ICMJE Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
Brief Summary Chronic diseases such as diabetes, cardiovascular diseases and cancer are a major burden on the Scottish population. Obesity and inflammation have strong links to these diseases. One of the mechanisms explaining the relationship between low-grade inflammation and excess weight is "endotoxaemia". We wish to study this phenomenon, when small components coming from our gut bacteria can pass into the bloodstream, raising the body's defences. Diet can modulate endotoxaemia. In this study, we propose to use curcumin, in a capsule form, to modulate endotoxaemia. Curcumin comes from turmeric, which is widely used as a spice. In this study, we want to test the effect of consuming curcumin extract to the composition of the gut microbiota, post-meal endotoxaemia, and inflammatory markers in blood.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Overweight
Intervention  ICMJE
  • Dietary Supplement: BCM-95
    Consuming 1 capsule of BCM-95 per day.
    Other Name: Bio-Curcumin
  • Dietary Supplement: Placebo
    Consuming 1 placebo capsule per day
Study Arms  ICMJE
  • Experimental: Trial
    350 mg of BCM-95, 1 capsule per day, for 21 days.
    Intervention: Dietary Supplement: BCM-95
  • Placebo Comparator: Control
    350 mg of starch, 1 capsule per day, for 21 days
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
16
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- BMI > 25 kg/m2.

Exclusion Criteria:

  • having chronic inflammatory or autoimmune disease, gastrointestinal complaints or known biliary obstruction (past and present)
  • use of anti-inflammatory drugs 2 weeks before the start of the study
  • use of antibiotics during the 12 weeks preceding the trial
  • pregnancy
  • lactation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03329781
Other Study ID Numbers  ICMJE 200130089
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emilie Combet, University of Glasgow
Study Sponsor  ICMJE University of Glasgow
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Glasgow
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP