HypercholesterolemiaNCT01566266
Gut Flora and Lipid Metabolism
A study testing Amoxicillin in people with Hypercholesterolemia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
It is well known that metabolic responses to diet and drugs are affected by genetic and environmental factors. Still, a large part of differences in responses between individuals remains unexplained. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Apr 2013
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 18-70 years
- serum total cholesterol: 5-8mmol/L
Who cannot join
- serum triacylglycerol > 3.0mmol/L
- use of oral anticonceptives
- pregnant or breastfeeding women
- kidney insufficiencies
- unstable body weight
- allergy to antibiotics
Show all 14Show fewer
- treatment with cholesterol-lowering drugs
- use of medication or a medically prescribed diet
- active cardiovascular disease
- abuse of drugs
- more than 21 alcohol consumptions per week for men and 14 consumptions for women
- use of an investigational product within the previous 30 days
- not willing to stop the consumption of products rich in plant stanol or sterol esters 3 weeks before start of the study
- use of gastric acid inhibitors, laxantia, prebiotica, probiotica and antibiotica for at least one month before the start of the study and during the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg
About this study
It is well known that metabolic responses to diet and drugs are affected by genetic and environmental factors. Still, a large part of differences in responses between individuals remains unexplained. To increase our understanding of individual differences, more and more attention is paid to the role of intestinal microbiota. Not only energy and glucose may be related to the microbiota, but also lipid metabolism. This is not surprising as lipid metabolism, glucose metabolism, and obesity are closely linked.
There is substantial evidence from in particular animal studies that the gut microbiota is related to lipid and lipoprotein metabolism. However, there is less evidence to what extent modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.
- Conditions
- Hypercholesterolemia
- Being tested
- Amoxicillin, Placebo capsule
- Keywords
- gut flora, antibiotics, lipid metabolism, LDL cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
2 capsules of 250mg, 3 times per day during 1 week
Placebo capsuleDrug
2 capsules of 250mg, 3 times per day during 1 week
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Experimental | Not described Receives: Drug: Amoxicillin |
| Placebo capsules | Placebo comparator | Not described Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol
Measured: Measure change between day 1 and day 8
Secondary outcomes (2)
Lipid metabolism
Measured: Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)
Glucose metabolism
Measured: Measure change between day 1 and day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Mensink, Prof. Dr. Ir., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566266
- Sponsor's protocol ID
- METC 12-3-011
- Status last verified
- May 2013
- First submitted
- 27 Mar 2012
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Flora and Lipid Metabolism
- ClinicalTrials.gov ID
- NCT01566266
- Acronym / sponsor ID
- METC 12-3-011
- Conditions
- Hypercholesterolemia
- Keywords
- gut flora, antibiotics, lipid metabolism, LDL cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Mar 2012 (estimated)
- 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.
It is well known that metabolic responses to diet and drugs are affected by genetic and environmental factors. Still, a large part of differences in responses between individuals remains unexplained. To increase our understanding of individual differences, more and more attention is paid to the role of intestinal microbiota. Not only energy and glucose may be related to the microbiota, but also lipid metabolism. This is not surprising as lipid metabolism, glucose metabolism, and obesity are closely linked.
There is substantial evidence from in particular animal studies that the gut microbiota is related to lipid and lipoprotein metabolism. However, there is less evidence to what extent modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Experimental | Drug: Amoxicillin |
| Placebo capsules | Placebo comparator | Drug: Placebo capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 18-70 years
- serum total cholesterol: 5-8mmol/L
Key exclusion criteria (14 listed)
- serum triacylglycerol > 3.0mmol/L
- use of oral anticonceptives
- pregnant or breastfeeding women
- kidney insufficiencies
- unstable body weight
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 |
|---|---|---|
| Amoxicillin2 capsules of 250mg, 3 times per day during 1 week | Drug | Amoxicillin |
| Placebo capsule2 capsules of 250mg, 3 times per day during 1 week | Drug | Placebo capsules |
Primary outcome
LDL-cholesterol
Time frame: Measure change between day 1 and day 8
2 secondary outcomes
Lipid metabolism
Time frame: Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)
Glucose metabolism
Time frame: Measure change between day 1 and day 8
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 14 May 2013.
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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.
Ronald Mensink, Prof. Dr. Ir. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin in people with Hypercholesterolemia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 14 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 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
LDL-cholesterol (time frame: Measure change between day 1 and day 8). 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 14 May 2013.