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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Trial

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

Group Type EXPERIMENTAL

BCM-95

Intervention Type DIETARY_SUPPLEMENT

Consuming 1 capsule of BCM-95 per day.

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Consuming 1 placebo capsule per day

Interventions

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BCM-95

Consuming 1 capsule of BCM-95 per day.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Consuming 1 placebo capsule per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bio-Curcumin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes