Glycemic Effects of Honey

Study Overview
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Brief Summary
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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
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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.

Official Title
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Glycemic Effects of Honey

Conditions
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Pre-diabetes

Intervention / Treatment
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* Dietary Supplement: Honey
* Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)
* Dietary Supplement: CHO (sugar)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Honey<br>60.7 grams daily orally times 14 days | Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)<br>* 65.7 gram daily orally times 14 days<br>Dietary Supplement: CHO (sugar)<br>* 50 grams daily orally times 14 days<br>|
| Active Comparator: CHO<br>50 grams daily orally times 14 days | Dietary Supplement: Honey<br>* 60.7 grams orally daily times 14 days<br>Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)<br>* 65.7 gram daily orally times 14 days<br>|
| Active Comparator: High Fructose Corn Syrup<br>65.7 grams daily orally times 14 days | Dietary Supplement: Honey<br>* 60.7 grams orally daily times 14 days<br>Dietary Supplement: CHO (sugar)<br>* 50 grams daily orally times 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin- 120 min OGTT - AUC | Evaluation of the effect of the treatment nutritive sweeteners on insulin sensitivity. | 15 weeks | 
| Triglycerides - 120 min OGTT - AUC | Evaluation of the effect of the treatment nutritive sweeteners on fat metabolism. | 15 weeks | 
| Inflammatory Markers | Effect of nutritive sweetener intake on systemic inflammation. | 15 weeks | 
| Oxidative Stress Markers | Effect of nutritive sweetener intake on systemic oxidative stress. | 15 weeks | 
| Serum Lipids | Effect of nutritive sweetener intake on lipid metabolism. | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose intolerance, Insulin resistance, Insulin, metabolic syndrome, honey, Inflammation, oxidative stress