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The Effect of Hesperidin on Glucose / Insulin Metabolism

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ClinicalTrials.gov Identifier: NCT02610491
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Bouke Salden, Maastricht University Medical Center

Brief Summary:

Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition, overweight has a causal relationship with a chronic low grade systemic inflammatory condition and increased intestinal permeability. Over the last decade, this multiplex disorder has progressively become a major worldwide public health problem, because of its association with increased risk of type 2 diabetes mellitus (DM2), atherosclerotic cardiovascular disease and all-cause mortality. Scientific evidence for measures to improve cardiometabolic and intestinal health by non-pharmaceutical means are of urgent need. Administration of the flavonoid hesperidin to those at risk may have beneficial effects on glucose / insulin metabolism, lipid metabolism, blood pressure, heart rate, pro-inflammatory and oxidative stress biomarkers and gut barrier function.

Objective: To determine the 12-week effect of daily administration of hesperidin on the main cardiometabolic disorders related to MS as assessed by investigation of glucose/insulin metabolism, blood lipid profile, blood pressure, heart rate, body composition and gut barrier function in subjects at risk for MS.

Study design: This is a randomized, double-blind, placebo-controlled study with parallel design.

Study population: Healthy (male/female) volunteers, age 18-65, at risk for metabolic syndrome (presenting with 2 out of 5 of the components from NCEP-ATP-III criteria).

Intervention: Participants will be randomly assigned to one of the intervention groups. One group will receive one daily dose of hesperidin capsules while the other group receives identical looking placebo capsules for a period of 12 weeks. The capsules will have to be ingested with a glass of water every morning just before breakfast.

Main study parameters/endpoints: The primary efficacy parameter of this study is the oral glucose tolerance test (OGTT), a validated surrogate endpoint to study the β-cell function and insulin sensitivity. Secondary endpoints entail the evaluation of effects of daily administration of hesperidin on lipid profile (blood measurements), blood pressure and heart rate, body composition, low-grade inflammation biomarkers (blood measurements) and gut barrier function (blood measurements, fecal samples, urine collection).


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Dietary Supplement: Hesperidin Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Hesperidin Administration on Glucose / Insulin Metabolism
Study Start Date : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Cellulose
Dietary Supplement: Placebo
Cellulose

Active Comparator: Hesperidin
Citrus peel extract
Dietary Supplement: Hesperidin
Citrus peel extract




Primary Outcome Measures :
  1. Effect on blood glucose concentrations measured by oral glucose tolerance test [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Effect on blood lipid profile [ Time Frame: 12 weeks ]
  2. Effect on blood pressure [ Time Frame: 12 weeks ]
  3. Effect on body composition measured by BMI [ Time Frame: 12 weeks ]
  4. Effect on low-grade inflammation measured by blood concentration of TNFalfa [ Time Frame: 12 weeks ]
  5. Effect on low-grade inflammation measured by blood concentration of interleukin-6 [ Time Frame: 12 weeks ]
  6. Effect on gut barrier function measured by a sugar test [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

* Subjects at risk for metabolic syndrome: a combination of 2 out of 5 components:

  • Waist circumference: men > 102 cm / women > 88 cm
  • Triglycerides: ≥ 1.7 mmol/l
  • HDL-cholesterol: men ≤ 1.0 mmol/l / women ≤ 1.3 mmol/l
  • Systolic blood pressure: ≥ 130 mmHg or diastolic blood pressure: ≥ 85 mmHg
  • Fasted serum glucose ≥ 6.1 mmol/L

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
  • 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) or lactation
  • Blood donation within 3 months before study period
  • Failure to comply prohibited intake of hesperidin containing food products during study period. A list with forbidden products will be provided to participants
  • 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): NCT02610491


Locations
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Netherlands
MUMC+
Maastricht, Limburg, Netherlands, 6221EG
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Ad Masclee, MD Maastricht University Medical Center
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Responsible Party: Bouke Salden, MD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02610491    
Other Study ID Numbers: 143036
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases