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NCT Number: NCT02228291

The Effect of Citric Flavonoid on Endothelial 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsule containing citrus flavonoid

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2014
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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