Effects of Hesperidin on Insulin Sensitivity (EHIS)
Obesity, Insulin Resistance
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Insulin Resistance, Endothelial dysfunction, Blood pressure
Eligibility 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.
Sites / Locations
- University of Maryland
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Hesperidin
Placebo
Subjects will receive oral hesperidin 500 mg/day
subjects will receive matching placebo to hesperidin daily for 1 month