Glycemic Effects of Honey
Primary Purpose
Pre-diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Honey
High Fructose Corn Syrup 55 (HFCS 55)
CHO (sugar)
Sponsored by
About this trial
This is an interventional basic science trial for Pre-diabetes focused on measuring Glucose intolerance, Insulin resistance, Insulin, metabolic syndrome, honey, Inflammation, oxidative stress
Eligibility Criteria
Inclusion Criteria:
- Men and women between 20-80 years of age.
Normal Glucose Tolerance
- Fasting glucose between ≤105 mg/dl
- Normal body weight or overweight (BMI 18-29.9)
Impaired Glucose Tolerance
- Fasting glucose between 106-125 mg/dl
- Overweight or obese (BMI 25 - 39.9)
- Willingness to comply with the demands of the experimental protocol
- Sedentary Lifestyle
Exclusion Criteria:
- Known uncontrolled disease process
- Diabetes mellitus
- Use of medications that affect glucose metabolism
- History of an eating disorder
- Pregnancy or breast feeding
- Inability to give consent
- Unwillingness or inability to consume the supplemental sugars
Sites / Locations
- Grand Forks Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Honey
CHO
High Fructose Corn Syrup
Arm Description
60.7 grams daily orally times 14 days
50 grams daily orally times 14 days
65.7 grams daily orally times 14 days
Outcomes
Primary Outcome Measures
Area under the curve glucose, response for OGTT. Glucose-120 min OGTT-AUC
Evaluation of the effect of the treatment nutritive sweeteners on glucose tolerance.
Secondary Outcome Measures
Insulin- 120 min OGTT - AUC
Evaluation of the effect of the treatment nutritive sweeteners on insulin sensitivity.
Triglycerides - 120 min OGTT - AUC
Evaluation of the effect of the treatment nutritive sweeteners on fat metabolism.
Inflammatory Markers
Effect of nutritive sweetener intake on systemic inflammation.
Oxidative Stress Markers
Effect of nutritive sweetener intake on systemic oxidative stress.
Serum Lipids
Effect of nutritive sweetener intake on lipid metabolism.
Full Information
NCT ID
NCT01371266
First Posted
June 3, 2011
Last Updated
August 1, 2018
Sponsor
USDA Grand Forks Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01371266
Brief Title
Glycemic Effects of Honey
Official Title
Glycemic Effects of Honey
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Glucose intolerance, Insulin resistance, Insulin, metabolic syndrome, honey, Inflammation, oxidative stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Honey
Arm Type
Active Comparator
Arm Description
60.7 grams daily orally times 14 days
Arm Title
CHO
Arm Type
Active Comparator
Arm Description
50 grams daily orally times 14 days
Arm Title
High Fructose Corn Syrup
Arm Type
Active Comparator
Arm Description
65.7 grams daily orally times 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Honey
Intervention Description
60.7 grams orally daily times 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
High Fructose Corn Syrup 55 (HFCS 55)
Intervention Description
65.7 gram daily orally times 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
CHO (sugar)
Intervention Description
50 grams daily orally times 14 days
Primary Outcome Measure Information:
Title
Area under the curve glucose, response for OGTT. Glucose-120 min OGTT-AUC
Description
Evaluation of the effect of the treatment nutritive sweeteners on glucose tolerance.
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Insulin- 120 min OGTT - AUC
Description
Evaluation of the effect of the treatment nutritive sweeteners on insulin sensitivity.
Time Frame
15 weeks
Title
Triglycerides - 120 min OGTT - AUC
Description
Evaluation of the effect of the treatment nutritive sweeteners on fat metabolism.
Time Frame
15 weeks
Title
Inflammatory Markers
Description
Effect of nutritive sweetener intake on systemic inflammation.
Time Frame
15 weeks
Title
Oxidative Stress Markers
Description
Effect of nutritive sweetener intake on systemic oxidative stress.
Time Frame
15 weeks
Title
Serum Lipids
Description
Effect of nutritive sweetener intake on lipid metabolism.
Time Frame
15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women between 20-80 years of age.
Normal Glucose Tolerance
Fasting glucose between ≤105 mg/dl
Normal body weight or overweight (BMI 18-29.9)
Impaired Glucose Tolerance
Fasting glucose between 106-125 mg/dl
Overweight or obese (BMI 25 - 39.9)
Willingness to comply with the demands of the experimental protocol
Sedentary Lifestyle
Exclusion Criteria:
Known uncontrolled disease process
Diabetes mellitus
Use of medications that affect glucose metabolism
History of an eating disorder
Pregnancy or breast feeding
Inability to give consent
Unwillingness or inability to consume the supplemental sugars
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K. Raatz, PhD., RD
Organizational Affiliation
Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11063439
Citation
Bantle JP, Raatz SK, Thomas W, Georgopoulos A. Effects of dietary fructose on plasma lipids in healthy subjects. Am J Clin Nutr. 2000 Nov;72(5):1128-34. doi: 10.1093/ajcn/72.5.1128.
Results Reference
background
PubMed Identifier
19353539
Citation
Mathern JR, Raatz SK, Thomas W, Slavin JL. Effect of fenugreek fiber on satiety, blood glucose and insulin response and energy intake in obese subjects. Phytother Res. 2009 Nov;23(11):1543-8. doi: 10.1002/ptr.2795.
Results Reference
background
PubMed Identifier
16177201
Citation
Raatz SK, Torkelson CJ, Redmon JB, Reck KP, Kwong CA, Swanson JE, Liu C, Thomas W, Bantle JP. Reduced glycemic index and glycemic load diets do not increase the effects of energy restriction on weight loss and insulin sensitivity in obese men and women. J Nutr. 2005 Oct;135(10):2387-91. doi: 10.1093/jn/135.10.2387.
Results Reference
background
PubMed Identifier
16249527
Citation
Shah M, Adams-Huet B, Bantle JP, Henry RR, Griver KA, Raatz SK, Brinkley LJ, Reaven GM, Garg A. Effect of a high-carbohydrate versus a high--cis-monounsaturated fat diet on blood pressure in patients with type 2 diabetes. Diabetes Care. 2005 Nov;28(11):2607-12. doi: 10.2337/diacare.28.11.2607.
Results Reference
background
PubMed Identifier
17242212
Citation
Andreozzi F, Laratta E, Procopio C, Hribal ML, Sciacqua A, Perticone M, Miele C, Perticone F, Sesti G. Interleukin-6 impairs the insulin signaling pathway, promoting production of nitric oxide in human umbilical vein endothelial cells. Mol Cell Biol. 2007 Mar;27(6):2372-83. doi: 10.1128/MCB.01340-06. Epub 2007 Jan 22.
Results Reference
background
PubMed Identifier
26338891
Citation
Raatz SK, Johnson LK, Picklo MJ. Consumption of Honey, Sucrose, and High-Fructose Corn Syrup Produces Similar Metabolic Effects in Glucose-Tolerant and -Intolerant Individuals. J Nutr. 2015 Oct;145(10):2265-72. doi: 10.3945/jn.115.218016. Epub 2015 Sep 2.
Results Reference
derived
Learn more about this trial
Glycemic Effects of Honey
We'll reach out to this number within 24 hrs