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.
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
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 group | Role | What they receive |
|---|---|---|
| Honey | Active comparator | 60.7 grams daily orally times 14 days Receives: Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55); Dietary Supplement: CHO (sugar) |
| CHO | Active comparator | 50 grams daily orally times 14 days Receives: Dietary Supplement: Honey; Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55) |
| High Fructose Corn Syrup | Active comparator | 65.7 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.
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)
Insulin- 120 min OGTT - AUC
Evaluation of the effect of the treatment nutritive sweeteners on insulin sensitivity.
Measured: 15 weeks
Triglycerides - 120 min OGTT - AUC
Evaluation of the effect of the treatment nutritive sweeteners on fat metabolism.
Measured: 15 weeks
Inflammatory Markers
Effect of nutritive sweetener intake on systemic inflammation.
Measured: 15 weeks
Oxidative Stress Markers
Effect of nutritive sweetener intake on systemic oxidative stress.
Measured: 15 weeks
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.
- First posted10 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan K. Raatz, PhD., RD, Principal investigator, Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center
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 11063439Mathern 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 19353539Raatz 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 16177201Shah 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 16249527Andreozzi 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 17242212Raatz 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Effects of Honey
- ClinicalTrials.gov ID
- NCT01371266
- Acronym / sponsor ID
- GFHNRC021
- Conditions
- Pre-diabetes
- Keywords
- Glucose intolerance, Insulin resistance, Insulin, metabolic syndrome, honey, Inflammation, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jun 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Honey | Active comparator | Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55), Dietary Supplement: CHO (sugar)60.7 grams daily orally times 14 days |
| CHO | Active comparator | Dietary Supplement: Honey, Dietary Supplement: High Fructose Corn Syrup 55 (HFCS 55)50 grams daily orally times 14 days |
| High Fructose Corn Syrup | Active comparator | Dietary Supplement: Honey, Dietary Supplement: CHO (sugar)65.7 grams daily orally times 14 days |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women between 20-80 years of age.
- Normal Glucose Tolerance
- Impaired Glucose Tolerance
- Willingness to comply with the demands of the experimental protocol
- Sedentary Lifestyle
Key exclusion criteria (7 listed)
- Known uncontrolled disease process
- Diabetes mellitus
- Use of medications that affect glucose metabolism
- History of an eating disorder
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honey60.7 grams orally daily times 14 days | Dietary supplement | CHO, High Fructose Corn Syrup |
| High Fructose Corn Syrup 55 (HFCS 55)65.7 gram daily orally times 14 days | Dietary supplement | CHO, Honey |
| CHO (sugar)50 grams daily orally times 14 days | Dietary supplement | High Fructose Corn Syrup, Honey |
Primary outcome
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.
5 secondary outcomes
Insulin- 120 min OGTT - AUC
Time frame: 15 weeks
Triglycerides - 120 min OGTT - AUC
Time frame: 15 weeks
Inflammatory Markers
Time frame: 15 weeks
Oxidative Stress Markers
Time frame: 15 weeks
Serum Lipids
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 11063439Bantle 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.
- Background: PubMed 19353539Mathern 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.
- Background: PubMed 16177201Raatz 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.
- Background: PubMed 16249527Shah 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.
- Background: PubMed 17242212Andreozzi 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.
- Derived from this study: PubMed 26338891Raatz 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.
- Click here for information about this study: Glycemic Effects of HoneyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan K. Raatz, PhD., RD principal investigator
Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 6 Nov 2026.