NCT01371266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

3.5 years

First QC Date

June 3, 2011

Last Update Submit

August 1, 2018

Conditions

Keywords

Glucose intoleranceInsulin resistanceInsulinmetabolic syndromehoneyInflammationoxidative stress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Insulin- 120 min OGTT - AUC

    15 weeks

  • Triglycerides - 120 min OGTT - AUC

    15 weeks

  • Inflammatory Markers

    15 weeks

  • Oxidative Stress Markers

    15 weeks

  • Serum Lipids

    15 weeks

Study Arms (3)

Honey

ACTIVE COMPARATOR

60.7 grams daily orally times 14 days

Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)Dietary Supplement: CHO (sugar)

CHO

ACTIVE COMPARATOR

50 grams daily orally times 14 days

Dietary Supplement: HoneyDietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)

High Fructose Corn Syrup

ACTIVE COMPARATOR

65.7 grams daily orally times 14 days

Dietary Supplement: HoneyDietary Supplement: CHO (sugar)

Interventions

HoneyDIETARY_SUPPLEMENT

60.7 grams orally daily times 14 days

CHOHigh Fructose Corn Syrup

65.7 gram daily orally times 14 days

CHOHoney
CHO (sugar)DIETARY_SUPPLEMENT

50 grams daily orally times 14 days

High Fructose Corn SyrupHoney

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58201, United States

Location

Related Publications (6)

  • 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.

    PMID: 11063439BACKGROUND
  • 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.

    PMID: 19353539BACKGROUND
  • 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.

    PMID: 16177201BACKGROUND
  • 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.

    PMID: 16249527BACKGROUND
  • 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.

    PMID: 17242212BACKGROUND
  • 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.

MeSH Terms

Conditions

Glucose IntoleranceInsulin ResistanceMetabolic SyndromeInflammation

Interventions

HoneySugars

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCarbohydrates

Study Officials

  • Susan K. Raatz, PhD., RD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 10, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations