Effects of Hesperidin on Insulin Sensitivity (EHIS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Michael Quon, University of Maryland
ClinicalTrials.gov Identifier:
NCT01773486
First received: January 17, 2013
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

This study will examine whether hesperidin, a major component of citrus fruits, affects how the body responds to insulin in healthy and obese people. Laboratory studies suggest that hesperidin treatment lowers blood pressure, lowers blood sugar and increases blood flow. This study will see if hesperidin improves insulin resistance or insulin's effects on blood flow in people with insulin resistance.

Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for this study. Participants are randomly assigned to take hesperidin or a placebo (inactive dummy pill ) for a 4-week treatment phase.


Condition Intervention Phase
Obesity
Insulin Resistance
Drug: Hesperidin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Evaluate the Ability of the Citrus Polyphenol Hesperidin to Improve Insulin Sensitivity in Healthy Subjects and to Ameliorate Insulin Resistance in Obese Subjects

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • insulin sensitivity (determined by glucose clamp) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    To determine if oral hesperidin consumption (500 mg p.o. daily for 1 month) improves insulin sensitivity (determined by glucose clamp) in healthy individuals or improves insulin resistance in subjects with obesity when compared with placebo treatment


Secondary Outcome Measures:
  • basal hepatic glucose production [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Determine whether or not hesperidin treatment reduces basal hepatic glucose production in obese and lean subjects using tracer-labeled glucose.

  • endothelial function [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Determine if oral hesperidin consumption (500 mg p.o. daily for 1 month) improves baseline and insulin-stimulated endothelial function as measured by finger plethysmography via Endo-PAT (before and during glucose clamp studies)

  • blood pressure [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Determine if oral hesperidin treatment reduces systolic and/or diastolic blood pressure in obese and lean subjects.

  • Inflammatory markers [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Determine if oral hesperidin consumption (500 mg p.o. daily for 1 month) alters plasma levels of pro- and anti-inflammatory cytokines


Other Outcome Measures:
  • pharmacokinetics [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Determine steady-state levels of hesperidin before and after 1 month treatment with hesperidin or placebo. Determine hesperidin pharmacokinetics in plasma after oral administration of hesperidin (500 mg)


Estimated Enrollment: 140
Study Start Date: June 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hesperidin
Subjects will receive oral hesperidin 500 mg/day
Drug: Hesperidin
Citrus polyphenol, hesperidin
Placebo Comparator: Placebo
subjects will receive matching placebo to hesperidin daily for 1 month

Detailed Description:

This study will examine whether hesperidin, a major component of citrus fruits, affects how the body responds to insulin in healthy and obese people. Insulin is not as effective in people who are overweight, have high blood pressure or diabetes. This condition is known as insulin resistance. Laboratory studies suggest that hesperidin treatment lowers blood pressure, lowers blood sugar and increases blood flow. This study will see if hesperidin improves insulin resistance or insulin's effects on blood flow in people with insulin resistance.

Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for this study. Participants are randomly assigned to take hesperidin or a placebo (inactive dummy pill ) for a 4-week treatment phase. In addition to treatment, participants undergo the following procedures during the study period:

Screening, including medical history, physical examination and blood and urine tests.

Complete a dietary and physical activity questionnaire and consult with a dietitian

Blood and urine tests

At-home and clinic blood pressure monitoring

Glucose clamp test to measure how the body responds to insulin. This test is done two times during the study. A needle is placed in a vein in each of the subject's arms, one for sampling blood and the other for infusing insulin, glucose and potassium. Glucose and insulin levels, electrolytes, lipids, fatty acids, cytokines and hesperidin levels are measured. We will also use tracer-labeled glucose to determine how much glucose the body produces in the fasting state and during the clamp. This type of glucose has low levels of radiation.

Forearm blood flow measurement with finger plethysmography device. Before beginning the glucose clamp test, a test of how well the blood vessels relax is done. A device that measures the blood flow in the vessels of the forefingers is used. The test is performed at the before the glucose clamp test and again 2 hours after the beginning of the clamp.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy Subjects - Men and women in good general health with no significant underlying illnesses who are between the ages of 21 - 65 years of age with HbA1C < 5.7 %, fasting blood glucose < 100 mg/dL, blood pressure less than 120/80, and BMI between 20 - 25 kg/m2. Subjects should have never smoked tobacco or not smoked within the previous year.

Obese Subjects - Men and women in good general health with no significant underlying illnesses except obesity who are between the ages of 21 - 65 years of age with HbA1C < 5.7 %, fasting blood glucose < 100 mg/dl, blood pressure less than 130/90, and BMI between 30 - 45 kg/m2.

Exclusion Criteria:

  • Subjects will be excluded from our study if they are pregnant, breastfeeding, or if they plan pregnancy prior to the end of the study. In addition, subjects will be excluded if their age > 65 yrs, BMI ≥ 45 kg/m2, or have liver disease (including liver transaminase levels greater than twice the upper limit of normal), pulmonary disease, renal insufficiency (serum creatinine greater than 2.0 mg/dl), coronary heart disease, heart failure (New York Heart Association heart failure Class III or IV), peripheral vascular disease, coagulopathy, Major depressive disorder, actively smoking or used tobacco within last year, history of cancer, in treatment for any form of cancer, positive tests for HIV, hepatitis B or C, or take systemic corticosteroids, thiazolidinediones (within 3 months), insulin, or anticoagulants, use food supplements that cannot be discontinued, regular intake of 8 or more cups of tea per week within 3 months prior to study entry, regular alcoholic beverage intake of more than two drinks per day (a drink corresponds to approximately 12 ounces of beer, 4 ounces of table wine, and between 1 and 1.5 ounces of 80-proof spirits), poor compliance during run-in period or regular use of medications that affect insulin sensitivity, blood pressure or vascular function and that cannot be discontinued. In addition, history of any other medical disease, laboratory abnormalities, or psychological conditions that would make the subject (based upon the principal investigator's judgment) unsuitable for study enrollment. Subjects will be excluded if they are unable to give informed consent for all procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773486

Contacts
Contact: Kashif Munir, MD 410-328-6219 kmunir@medicine.umaryland.edu

Locations
United States, Maryland
University of Maryland Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Kashif Munir, MD    410-328-6219    kmunir@medicine.umaryland.edu   
Principal Investigator: Michael J Quon, MD, PhD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Michael J Quon, MD, PhD University of Maryland
  More Information

Publications:
Responsible Party: Michael Quon, Professor of Medicine, University of Maryland
ClinicalTrials.gov Identifier: NCT01773486     History of Changes
Other Study ID Numbers: HP-00051658
Study First Received: January 17, 2013
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Obesity
Insulin Resistance
Endothelial dysfunction
Blood pressure

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014