Glycemic Effects of Honey

August 1, 2018 updated by: USDA Grand Forks Human Nutrition Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Grand Forks Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Honey
60.7 grams daily orally times 14 days
Dietary supplement: High Fructose Corn Syrup 55 (HFCS 55)
65.7 gram daily orally times 14 days
Dietary supplement: CHO (sugar)
50 grams daily orally times 14 days
Active Comparator: CHO
50 grams daily orally times 14 days
Dietary supplement: High Fructose Corn Syrup 55 (HFCS 55)
65.7 gram daily orally times 14 days
Dietary supplement: Honey
60.7 grams orally daily times 14 days
Active Comparator: High Fructose Corn Syrup
65.7 grams daily orally times 14 days
Dietary supplement: CHO (sugar)
50 grams daily orally times 14 days
Dietary supplement: Honey
60.7 grams orally daily times 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve glucose, response for OGTT. Glucose-120 min OGTT-AUC
Time Frame: 15 weeks
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
Time Frame: 15 weeks
Evaluation of the effect of the treatment nutritive sweeteners on insulin sensitivity.
15 weeks
Triglycerides - 120 min OGTT - AUC
Time Frame: 15 weeks
Evaluation of the effect of the treatment nutritive sweeteners on fat metabolism.
15 weeks
Inflammatory Markers
Time Frame: 15 weeks
Effect of nutritive sweetener intake on systemic inflammation.
15 weeks
Oxidative Stress Markers
Time Frame: 15 weeks
Effect of nutritive sweetener intake on systemic oxidative stress.
15 weeks
Serum Lipids
Time Frame: 15 weeks
Effect of nutritive sweetener intake on lipid metabolism.
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Grand Forks Human Nutrition Research Center

Investigators

  • Principal Investigator: Susan K. Raatz, PhD., RD, Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 3, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFHNRC021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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