Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-29 @ 5:16 AM
Study NCT ID:
NCT01371266
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2011-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Effects of Honey
Sponsor:
USDA Grand Forks Human Nutrition Research Center
Organization:
Study Overview
Official Title:
Glycemic Effects of Honey
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Honey has been used as a sweetener for centuries. Recent data indicate that honey consumption may have beneficial effects upon glucose intolerance, a health issue currently affecting 57 million Americans of every age and ethnicity. In order to evaluate the glycemic effect of honey, the investigators will carry out a human trial assessing biomarkers of blood glucose responses, insulin sensitivity, oxidative stress, and inflammatory markers. Our primary objective is to determine the glycemic effects of honey in comparison to sucrose and high fructose corn syrup (HFCS). The investigators hypothesize that honey will promote improved glucose tolerance and insulin sensitivity compared to both sucrose and high fructose corn syrup in normal glycemic and glucose intolerant adults.
Detailed Description:
Glucose intolerance and insulin resistance are associated with the development of the metabolic syndrome and chronic diseases, including, hyperlipidemia, hypertension, obesity, and type II diabetes. Current National Institutes of Health statistics estimate that 1 in 6 Americans have insulin resistance (www.diabetes.niddk.nih.gov/dm/pubs/statistics). Insulin resistance in humans is associated with glucose intolerance, enhanced oxidative stress, inflammation and alterations in lipid profiles. Improvements in glucose tolerance are associated with improved insulin sensitivity resulting in improved inflammatory and oxidative status. Dietary modification to reduced day-long serum insulin concentration is postulated to decrease hepatic cholesterol production through inhibition of HMG CoA reductase, the rate limiting enzyme involved in cholesterol synthesis.
Maintenance of normal blood glucose is dependent on the body's ability to modulate insulin secretion in response to the glucose load consumed. Although diet may be an important factor in glucose tolerance, the role of nutritive sweeteners has not been clearly defined. Much research has been performed on the effect of dietary sugars on chronic disease risk factors, including animal studies, and human studies ranging from epidemiologic to controlled feeding trials with most of this work focused on the monosaccharides: fructose and glucose or the disaccharide, sucrose.
Little work has been done on the comparative effects of honey and other nutritive sweeteners in relation to glucose tolerance and insulin sensitivity.
Maintenance of normal blood glucose is dependent on the body's ability to modulate insulin secretion in response to the glucose load consumed. Although diet may be an important factor in glucose tolerance, the role of nutritive sweeteners has not been clearly defined. Much research has been performed on the effect of dietary sugars on chronic disease risk factors, including animal studies, and human studies ranging from epidemiologic to controlled feeding trials with most of this work focused on the monosaccharides: fructose and glucose or the disaccharide, sucrose.
Little work has been done on the comparative effects of honey and other nutritive sweeteners in relation to glucose tolerance and insulin sensitivity.
Study Oversight
Has Oversight DMC:
True
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?: