Glycemic Effects of Honey

NCT ID: NCT01371266

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-08-31

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.

Conditions

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Pre-diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Honey

60.7 grams daily orally times 14 days

Group Type ACTIVE_COMPARATOR

High Fructose Corn Syrup 55 (HFCS 55)

Intervention Type DIETARY_SUPPLEMENT

65.7 gram daily orally times 14 days

CHO (sugar)

Intervention Type DIETARY_SUPPLEMENT

50 grams daily orally times 14 days

CHO

50 grams daily orally times 14 days

Group Type ACTIVE_COMPARATOR

Honey

Intervention Type DIETARY_SUPPLEMENT

60.7 grams orally daily times 14 days

High Fructose Corn Syrup 55 (HFCS 55)

Intervention Type DIETARY_SUPPLEMENT

65.7 gram daily orally times 14 days

High Fructose Corn Syrup

65.7 grams daily orally times 14 days

Group Type ACTIVE_COMPARATOR

Honey

Intervention Type DIETARY_SUPPLEMENT

60.7 grams orally daily times 14 days

CHO (sugar)

Intervention Type DIETARY_SUPPLEMENT

50 grams daily orally times 14 days

Interventions

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Honey

60.7 grams orally daily times 14 days

Intervention Type DIETARY_SUPPLEMENT

High Fructose Corn Syrup 55 (HFCS 55)

65.7 gram daily orally times 14 days

Intervention Type DIETARY_SUPPLEMENT

CHO (sugar)

50 grams daily orally times 14 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Men and women between 20-80 years of age.
2. Normal Glucose Tolerance

* Fasting glucose between ≤105 mg/dl
* Normal body weight or overweight (BMI 18-29.9)
3. Impaired Glucose Tolerance

* Fasting glucose between 106-125 mg/dl
* Overweight or obese (BMI 25 - 39.9)
4. Willingness to comply with the demands of the experimental protocol
5. Sedentary Lifestyle

Exclusion Criteria

1. Known uncontrolled disease process
2. Diabetes mellitus
3. Use of medications that affect glucose metabolism
4. History of an eating disorder
5. Pregnancy or breast feeding
6. Inability to give consent
7. Unwillingness or inability to consume the supplemental sugars
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan K. Raatz, PhD., RD

Role: PRINCIPAL_INVESTIGATOR

Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center

Locations

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Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11063439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19353539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16177201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16249527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17242212 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26338891 (View on PubMed)

Other Identifiers

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GFHNRC021

Identifier Type: -

Identifier Source: org_study_id

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