NCT03329781

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

October 30, 2017

Last Update Submit

April 27, 2021

Conditions

Overweight

Keywords

Endotoxaemia, Curcumin.

Outcome Measures

Primary Outcomes (1)

  • Level of endotoxin in plasma.

    21 days

Study Arms (2)

Trial

EXPERIMENTAL

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

Dietary Supplement: BCM-95

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

BCM-95DIETARY_SUPPLEMENT

Consuming 1 capsule of BCM-95 per day.

Also known as: Bio-Curcumin
Trial
PlaceboDIETARY_SUPPLEMENT

Consuming 1 placebo capsule per day

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- BMI \> 25 kg/m2.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightEndotoxemia

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

February 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 30, 2021

Record last verified: 2021-04