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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BCM-95
Placebo
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Endotoxaemia, Curcumin.

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Trial

    Control

    Arm Description

    350 mg of BCM-95, 1 capsule per day, for 21 days.

    350 mg of starch, 1 capsule per day, for 21 days

    Outcomes

    Primary Outcome Measures

    Level of endotoxin in plasma.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2017
    Last Updated
    April 27, 2021
    Sponsor
    University of Glasgow
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03329781
    Brief Title
    ENDOCUR - Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
    Acronym
    ENDOCUR
    Official Title
    Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Glasgow

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    Endotoxaemia, Curcumin.

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Trial
    Arm Type
    Experimental
    Arm Description
    350 mg of BCM-95, 1 capsule per day, for 21 days.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    350 mg of starch, 1 capsule per day, for 21 days
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    BCM-95
    Other Intervention Name(s)
    Bio-Curcumin
    Intervention Description
    Consuming 1 capsule of BCM-95 per day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Consuming 1 placebo capsule per day
    Primary Outcome Measure Information:
    Title
    Level of endotoxin in plasma.
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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