search
Back to results

The Effect of Citric Flavonoid on Endothelial Function

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Capsule containing citrus flavonoid
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Polyphenols, Endothelial function, Gut barrier function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Citric flavonoid

Arm Description

Cellulose

Citric flavonoid

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Glucose / insulin metabolism
The fourth secondary objective of this study is to determine the 6-week effect on glucose / insulin metabolism by blood measurements.
Lipid profile
The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements.
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.
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.
Colonic inflammation
The seventh secondary objective of this study is to assess the 6-week effect on colonic inflammation, by measuring fecal calprotectin.
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.

Full Information

First Posted
August 27, 2014
Last Updated
July 6, 2015
Sponsor
Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02228291
Brief Title
The Effect of Citric Flavonoid on Endothelial Function
Official Title
The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Polyphenols, Endothelial function, Gut barrier function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cellulose
Arm Title
Citric flavonoid
Arm Type
Experimental
Arm Description
Citric flavonoid
Intervention Type
Dietary Supplement
Intervention Name(s)
Capsule containing citrus flavonoid
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Endothelial function
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Endothelial function
Description
The second secondary objective of this study is to determine the 6-week effect on plasma biomarkers of endothelial dysfunction and low-grade inflammation.
Time Frame
6 weeks
Title
Blood pressure & heart rate
Description
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.
Time Frame
6 weeks
Title
Glucose / insulin metabolism
Description
The fourth secondary objective of this study is to determine the 6-week effect on glucose / insulin metabolism by blood measurements.
Time Frame
6 weeks
Title
Lipid profile
Description
The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements.
Time Frame
6 weeks
Title
Gut barrier function
Description
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.
Time Frame
6 weeks
Title
Gut barrier function
Description
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.
Time Frame
6 weeks
Title
Colonic inflammation
Description
The seventh secondary objective of this study is to assess the 6-week effect on colonic inflammation, by measuring fecal calprotectin.
Time Frame
6 weeks
Title
Bioavailability and metabolism
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.A.M. Masclee, MD, PhD
Organizational Affiliation
Department of Internal Medicine, Division of Gastroenterology-Hepatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27797708
Citation
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.
Results Reference
derived

Learn more about this trial

The Effect of Citric Flavonoid on Endothelial Function

We'll reach out to this number within 24 hrs