Ignite Creation Date:
2024-05-06 @ 1:16 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01773486
Status:
WITHDRAWN
Last Update Posted:
2022-03-04
First Post:
2013-01-17
Brief Title:
Effects of Hesperidin on Insulin Sensitivity
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EHIS
Brief Summary:
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 insulins 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
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
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 insulins 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 subjects 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
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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None