OverweightENDOCURNCT03329781
ENDOCUR - Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
A study testing BCM-95 in people with Overweight, run by University of Glasgow.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- BCM-95
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 25 kg/m2.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Overweight
- Being tested
- BCM-95, Placebo
- Keywords
- Endotoxaemia, Curcumin.
- Medical subject headings
- Overweight, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCM-95Dietary supplement
Also called Bio-Curcumin
Consuming 1 capsule of BCM-95 per day.
PlaceboDietary supplement
Consuming 1 placebo capsule per day
| Study group | Role | What they receive |
|---|---|---|
| Trial | Experimental | 350 mg of BCM-95, 1 capsule per day, for 21 days. Receives: Dietary Supplement: BCM-95 |
| Control | Placebo comparator | 350 mg of starch, 1 capsule per day, for 21 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of endotoxin in plasma.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study startFeb 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Combet, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329781
- Sponsor's protocol ID
- 200130089
- Acronym
- ENDOCUR
- Status last verified
- Apr 2021
- First submitted
- 30 Oct 2017
- Last updated
- 30 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
- ClinicalTrials.gov ID
- NCT03329781
- Acronym / sponsor ID
- ENDOCUR / 200130089
- Conditions
- Overweight
- Keywords
- Endotoxaemia, Curcumin.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial | Experimental | Dietary Supplement: BCM-95350 mg of BCM-95, 1 capsule per day, for 21 days. |
| Control | Placebo comparator | Dietary Supplement: Placebo350 mg of starch, 1 capsule per day, for 21 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI > 25 kg/m2.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCM-95Also: Bio-CurcuminConsuming 1 capsule of BCM-95 per day. | Dietary supplement | Trial |
| PlaceboConsuming 1 placebo capsule per day | Dietary supplement | Control |
Primary outcome
Level of endotoxin in plasma.
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BCM-95 in people with Overweight, run by University of Glasgow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of endotoxin in plasma. (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.