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

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ClinicalTrials.gov Identifier: NCT03329781
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Overweight Dietary Supplement: BCM-95 Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
Actual Study Start Date : February 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Trial
350 mg of BCM-95, 1 capsule per day, for 21 days.
Dietary Supplement: BCM-95
Consuming 1 capsule of BCM-95 per day.
Other Name: Bio-Curcumin

Placebo Comparator: Control
350 mg of starch, 1 capsule per day, for 21 days
Dietary Supplement: Placebo
Consuming 1 placebo capsule per day




Primary Outcome Measures :
  1. Level of endotoxin in plasma. [ Time Frame: 21 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Emilie Combet, Doctor, University of Glasgow
ClinicalTrials.gov Identifier: NCT03329781     History of Changes
Other Study ID Numbers: 200130089
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by Emilie Combet, University of Glasgow:
Endotoxaemia, Curcumin.

Additional relevant MeSH terms:
Curcumin
Overweight
Endotoxemia
Body Weight
Signs and Symptoms
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action