ObesityNCT02228291
The Effect of Citric Flavonoid on Endothelial Function
A study testing Capsule containing citrus flavonoid in people with Obesity and Overweight, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Capsule containing citrus flavonoid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Dec 2014
- 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
- Overweight men/women (BMI 25-35 kg/m2)
- Healthy individuals
- Age between 18 and 70 years
- Fasting glucose < 7.0 mmol/L
- Normal HbA1c (4.4 to 6.2%)
Who cannot join
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L)
- Gastroenterological diseases or abdominal surgery
- Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
- Self-admitted HIV-positive status
- Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
- Smoking
Show all 18Show fewer
- Plans to lose weight or following a hypocaloric diet during the study period
- Weight gain or loss > 3 kg in previous 3 months
- Use of medication interfering with endpoints
- Intake of antihypertensive medication, statins, corticosteroids, NSAIDs, ciclosporin A, rifampicin are strictly forbidden
- Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
- Hormone replacement therapy (women)
- Use of antibiotics in the 90 days prior to the start of study
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
- Known pregnancy (assessed by a pregnancy test before start of study), lactation
- Blood donation within 3 months before study period
- Failure to comply prohibited intake of hesperidin containing food products during study period and prohibited intake of food products that are able to influence the FMD measurements one day prior to test days.
- History of any side effects towards the intake of flavonoids or citrus fruits
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
About this study
Official title: The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function
This randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh subjects.
Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum levels of specific metabolites of the study product.
- Conditions
- Obesity, Overweight
- Being tested
- Capsule containing citrus flavonoid, Placebo
- Keywords
- Polyphenols, Endothelial function, Gut barrier function
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule containing citrus flavonoidDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Cellulose Receives: Dietary Supplement: Placebo |
| Citric flavonoid | Experimental | Citric flavonoid Receives: Dietary Supplement: Capsule containing citrus flavonoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
The primary objective of this study is to evaluate the efficacy on endothelial function, as assessed by flow mediated dilatation (FMD) measurements, after 6 weeks of administration of study product.
Measured: 6 weeks
Secondary outcomes (8)
Endothelial function
The second secondary objective of this study is to determine the 6-week effect on plasma biomarkers of endothelial dysfunction and low-grade inflammation.
Measured: 6 weeks
Blood pressure & heart rate
The third objective of this study is to assess the 6-week effect on blood pressure and heart rate by measuring systolic and diastolic blood pressure and heart rate.
Measured: 6 weeks
Glucose / insulin metabolism
The fourth secondary objective of this study is to determine the 6-week effect on glucose / insulin metabolism by blood measurements.
Measured: 6 weeks
Lipid profile
The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements.
Measured: 6 weeks
Gut barrier function
The fifth secondary objective of this study is to assess the acute and 6-week effect on gut barrier function by measuring plasma and fecal endotoxin (LPS) and zonulin.
Measured: 6 weeks
Gut barrier function
The sixth secondary objective of this study is to assess the 6-week effect of on gut barrier function by performing a gut sugar permeability test.
Measured: 6 weeks
Colonic inflammation
The seventh secondary objective of this study is to assess the 6-week effect on colonic inflammation, by measuring fecal calprotectin.
Measured: 6 weeks
Bioavailability and metabolism
The eight secondary objective of this study is to enlarge the understanding of the bioavailability and metabolism of this study product in human beings, by relating specific intestinal (microbial) metabolism with serum levels of its metabolites.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bouke Salden, Maastricht University Medical Center
- Investigators
- A.A.M. Masclee, MD, PhD, Principal investigator, Department of Internal Medicine, Division of Gastroenterology-Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228291
- Sponsor's protocol ID
- 13-3-019
- Status last verified
- Jul 2015
- First submitted
- 27 Aug 2014
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salden BN, Troost FJ, de Groot E, Stevens YR, Garces-Rimon M, Possemiers S, Winkens B, Masclee AA. Randomized clinical trial on the efficacy of hesperidin 2S on validated cardiovascular biomarkers in healthy overweight individuals. Am J Clin Nutr. 2016 Dec;104(6):1523-1533. doi: 10.3945/ajcn.116.136960. Epub 2016 Oct 26.
PubMed 27797708
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function
- ClinicalTrials.gov ID
- NCT02228291
- Acronym / sponsor ID
- 13-3-019
- Conditions
- Obesity, Overweight
- Keywords
- Polyphenols, Endothelial function, Gut barrier function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Aug 2014 (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.
This randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh subjects.
Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum levels of specific metabolites of the study product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCellulose |
| Citric flavonoid | Experimental | Dietary Supplement: Capsule containing citrus flavonoidCitric flavonoid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Overweight men/women (BMI 25-35 kg/m2)
- Healthy individuals
- Age between 18 and 70 years
- Fasting glucose < 7.0 mmol/L
- Normal HbA1c (4.4 to 6.2%)
Key exclusion criteria (18 listed)
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L)
- Gastroenterological diseases or abdominal surgery
- Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
- Self-admitted HIV-positive status
- Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
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 |
|---|---|---|
| Capsule containing citrus flavonoid | Dietary supplement | Citric flavonoid |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Endothelial function
Time frame: 6 weeks
The primary objective of this study is to evaluate the efficacy on endothelial function, as assessed by flow mediated dilatation (FMD) measurements, after 6 weeks of administration of study product.
8 secondary outcomes
Endothelial function
Time frame: 6 weeks
Blood pressure & heart rate
Time frame: 6 weeks
Glucose / insulin metabolism
Time frame: 6 weeks
Lipid profile
Time frame: 6 weeks
Gut barrier function
Time frame: 6 weeks
Gut barrier function
Time frame: 6 weeks
Colonic inflammation
Time frame: 6 weeks
Bioavailability and metabolism
Time frame: 5 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 8 Jul 2015.
- Derived from this study: PubMed 27797708Salden BN, Troost FJ, de Groot E, Stevens YR, Garces-Rimon M, Possemiers S, Winkens B, Masclee AA. Randomized clinical trial on the efficacy of hesperidin 2S on validated cardiovascular biomarkers in healthy overweight individuals. Am J Clin Nutr. 2016 Dec;104(6):1523-1533. doi: 10.3945/ajcn.116.136960. Epub 2016 Oct 26.
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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.
A.A.M. Masclee, MD, PhD principal investigator
Department of Internal Medicine, Division of Gastroenterology-Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule containing citrus flavonoid in people with Obesity and Overweight, 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 5 inclusion and 18 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 8 Jul 2015. 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?
Endothelial function (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228291, which also lists 1 linked publication.
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 8 Jul 2015.