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

Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: BCM-95; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Level of endotoxin in plasma.	21 days

Collaborators and Investigators

• Sponsor: University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Endotoxaemia, Curcumin.
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Body Weight; Sepsis; Bacteremia; Toxemia; Endotoxemia; Overweight; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 200130089