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The Effect of Citric Flavonoid on Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02228291
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bouke Salden, Maastricht University Medical Center

Brief 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 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.


Condition or disease Intervention/treatment Phase
Obesity Overweight Dietary Supplement: Capsule containing citrus flavonoid Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Cellulose
Dietary Supplement: Placebo
Experimental: Citric flavonoid
Citric flavonoid
Dietary Supplement: Capsule containing citrus flavonoid



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Endothelial function [ Time Frame: 6 weeks ]
    The second secondary objective of this study is to determine the 6-week effect on plasma biomarkers of endothelial dysfunction and low-grade inflammation.

  2. Blood pressure & heart rate [ Time Frame: 6 weeks ]
    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.

  3. Glucose / insulin metabolism [ Time Frame: 6 weeks ]
    The fourth secondary objective of this study is to determine the 6-week effect on glucose / insulin metabolism by blood measurements.

  4. Lipid profile [ Time Frame: 6 weeks ]
    The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements.

  5. Gut barrier function [ Time Frame: 6 weeks ]
    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.

  6. Gut barrier function [ Time Frame: 6 weeks ]
    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.

  7. Colonic inflammation [ Time Frame: 6 weeks ]
    The seventh secondary objective of this study is to assess the 6-week effect on colonic inflammation, by measuring fecal calprotectin.

  8. Bioavailability and metabolism [ Time Frame: 5 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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%)

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228291


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: A.A.M. Masclee, MD, PhD Department of Internal Medicine, Division of Gastroenterology-Hepatology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bouke Salden, Coordinating Investigator, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02228291    
Other Study ID Numbers: 13-3-019
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Keywords provided by Bouke Salden, Maastricht University Medical Center:
Polyphenols
Endothelial function
Gut barrier function
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Sodium Citrate
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action