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

June 3, 2011
June 23, 2014
June 2011
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01371266 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Glycemic Effects of Honey
Glycemic Effects of Honey

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pre-diabetes
  • 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
  • Dietary Supplement: CHO (sugar)
    50 grams daily orally times 14 days
  • Active Comparator: Honey
    60.7 grams daily orally times 14 days
    Interventions:
    • Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)
    • Dietary Supplement: CHO (sugar)
  • Active Comparator: CHO
    50 grams daily orally times 14 days
    Interventions:
    • Dietary Supplement: Honey
    • Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)
  • Active Comparator: High Fructose Corn Syrup
    65.7 grams daily orally times 14 days
    Interventions:
    • Dietary Supplement: Honey
    • Dietary Supplement: CHO (sugar)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
Yes
Contact: Susan K. Raatz, PhD., RD 701-795-8294 Susan.Raatz@ars.usda.gov
United States
 
NCT01371266
GFHNRC021
Yes
Susan Raatz, USDA Grand Forks Human Nutrition Research Center
USDA Grand Forks Human Nutrition Research Center
Not Provided
Principal Investigator: Susan K. Raatz, PhD., RD Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center
USDA Grand Forks Human Nutrition Research Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP