Glycemic Effects of Honey

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by USDA Grand Forks Human Nutrition Research Center
Sponsor:
Information provided by (Responsible Party):
Susan Raatz, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01371266
First received: June 3, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Pre-diabetes
Dietary Supplement: Honey
Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)
Dietary Supplement: CHO (sugar)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Glycemic Effects of Honey

Resource links provided by NLM:


Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Area under the curve glucose, response for OGTT. Glucose-120 min OGTT-AUC [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    Evaluation of the effect of the treatment nutritive sweeteners on glucose tolerance.


Secondary Outcome Measures:
  • Insulin- 120 min OGTT - AUC [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    Evaluation of the effect of the treatment nutritive sweeteners on insulin sensitivity.

  • Triglycerides - 120 min OGTT - AUC [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    Evaluation of the effect of the treatment nutritive sweeteners on fat metabolism.

  • Inflammatory Markers [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    Effect of nutritive sweetener intake on systemic inflammation.

  • Oxidative Stress Markers [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    Effect of nutritive sweetener intake on systemic oxidative stress.

  • Serum Lipids [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    Effect of nutritive sweetener intake on lipid metabolism.


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Honey
60.7 grams orally daily times 14 days
Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)
65.7 gram daily orally times 14 days
Active Comparator: High Fructose Corn Syrup
65.7 grams daily orally times 14 days
Dietary Supplement: Honey
60.7 grams orally daily times 14 days
Dietary Supplement: CHO (sugar)
50 grams daily orally times 14 days

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371266

Contacts
Contact: Susan K. Raatz, PhD., RD 701-795-8294 Susan.Raatz@ars.usda.gov

Locations
United States, North Dakota
Grand Forks Human Nutrition Research Center Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Angela Scheett, MPH, RD    701-795-8386    angela.scheett@ars.usda.gov   
Sub-Investigator: Matthew J. Picklo, PhD         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Susan Raatz, PhD, RD, Research Nutritionist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01371266     History of Changes
Other Study ID Numbers: GFHNRC021
Study First Received: June 3, 2011
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
Glucose intolerance
Insulin resistance
Insulin
metabolic syndrome
honey
Inflammation
oxidative stress

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 10, 2014