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Pre-diabetesNCT01371266

Glycemic Effects of Honey

A study testing Honey, High Fructose Corn Syrup 55 (HFCS 55) and CHO (sugar) in people with Pre-diabetes, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Pre-diabetes
What is being tested?
Honey, High Fructose Corn Syrup 55 (HFCS 55) and CHO (sugar)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
Jun 2011to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Overweight or obese (BMI 25 - 39.9)
  • Willingness to comply with the demands of the experimental protocol
  • Sedentary Lifestyle

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Grand Forks Human Nutrition Research Center

    Grand Forks, North Dakota, 58201

Other trials in United States

About this study

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.

Read the 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.

Conditions
Pre-diabetes
Being tested
Honey, High Fructose Corn Syrup 55 (HFCS 55), CHO (sugar)
Keywords
Glucose intolerance, Insulin resistance, Insulin, metabolic syndrome, honey, Inflammation, oxidative stress
Medical subject headings
Glucose Intolerance, Insulin Resistance, Metabolic Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HoneyDietary supplement

    60.7 grams orally daily times 14 days

  • High Fructose Corn Syrup 55 (HFCS 55)Dietary supplement

    65.7 gram daily orally times 14 days

  • CHO (sugar)Dietary supplement

    50 grams daily orally times 14 days

Study groups in NCT01371266
Study groupRoleWhat they receive
HoneyActive comparator60.7 grams daily orally times 14 days
Receives: Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55); Dietary Supplement: CHO (sugar)
CHOActive comparator50 grams daily orally times 14 days
Receives: Dietary Supplement: Honey; Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)
High Fructose Corn SyrupActive comparator65.7 grams daily orally times 14 days
Receives: Dietary Supplement: Honey; Dietary Supplement: CHO (sugar)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 weeks

Secondary outcomes (5)

  1. Insulin- 120 min OGTT - AUC

    Evaluation of the effect of the treatment nutritive sweeteners on insulin sensitivity.

    Measured: 15 weeks

  2. Triglycerides - 120 min OGTT - AUC

    Evaluation of the effect of the treatment nutritive sweeteners on fat metabolism.

    Measured: 15 weeks

  3. Inflammatory Markers

    Effect of nutritive sweetener intake on systemic inflammation.

    Measured: 15 weeks

  4. Oxidative Stress Markers

    Effect of nutritive sweetener intake on systemic oxidative stress.

    Measured: 15 weeks

  5. Serum Lipids

    Effect of nutritive sweetener intake on lipid metabolism.

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2014
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01371266
Sponsor's protocol ID
GFHNRC021
Status last verified
Aug 2018
First submitted
3 Jun 2011
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11063439

  • 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.

    PubMed 19353539

  • 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.

    PubMed 16177201

  • 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.

    PubMed 16249527

  • 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.

    PubMed 17242212

  • 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.

    PubMed 26338891

Questions about this trial

What is this clinical trial studying?

A study testing Honey, High Fructose Corn Syrup 55 (HFCS 55) and CHO (sugar) in people with Pre-diabetes, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve glucose, response for OGTT. Glucose-120 min OGTT-AUC (time frame: 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01371266, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.

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