- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06107231
WHNRC (Western Human Nutrition Research Center) Honey Study
The purpose of this research is to compare two snacks, one with honey and nuts and the other with sugar and nuts, on glucose levels before and after eating these snacks.
The investigators hypothesize that honey and nuts will have an additive effect on the reduction of postprandial glucose response. The investigators further hypothesize that consumption of honey paired with nuts will retain the benefit of sugar consumption in satiety and reduction of metabolic stress.
Study Overview
Status
Intervention / Treatment
Detailed Description
Consuming sugar creates a feeling of satiation, and may buffer metabolic stress. However, prolonged postprandial hyperglycemia has been identified as a potential risk factor in type 2 diabetes and cardiovascular disease. Nuts, which are recommended to be consumed as part of a Mediterranean diet, up to 2 servings per day, have been shown to dramatically reduce postprandial glucose response to carbohydrates. Additionally, honey, which is typically used as an added sugar within a Mediterranean diet pattern, has a lower glycemic index than table sugar and may result in a reduced postprandial glucose response relative to other nutritive sweeteners. However, it is not yet known whether honey can work additively with nuts to further reduce postprandial glucose response over the reduction caused by nuts alone.
Honey has been shown to produce equivalent or greater satiety to regular table sugar and there is some indication that honey can improve immediate/working memory. Therefore, combined consumption of honey and nuts may offer a way to maximize the benefits of carbohydrate consumption on satiety and metabolic stress reduction while minimizing its negative effects on metabolism. However, it is not yet known whether sugars contained in the more complex food matrix of honey, consumed together with a food like nuts can impact satiety and metabolic stress in the way that has been observed for sugar.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Davis, California, United States, 95616
- USDA, ARS, Western Human Nutrition Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women must be pre-menopausal
- Willing to consume snacks that contain honey, table sugar, and tree nuts
Exclusion Criteria:
- Body Mass Index (BMI) <18.5 or >40
- Allergies to tree nuts
- Current medical diagnoses of chronic diseases including cardiovascular or pulmonary diseases, renal diseases, cancer, type 1 or type 2 diabetes, thyroid disease requiring medication, inflammatory or irritable bowel diseases, or those with recent major surgeries
- No individuals who fall in to the vulnerable categories of adults including those unable to consent, pregnant women, children, or prisoners will be eligible for this study
- Routinely taking medications known to affect glucose response.
- Caffeine and alcohol use will not be excluded, but should be carefully reported by each subject.
Regarding female candidates:
- Post-menopausal
- Women who have been pregnant or nursing within the last 6 months or plan to become pregnant during the trial will be ineligible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Honey alone and honey with almonds, then sucrose alone and sucrose with almonds
Participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor.
After a 14 day wash-out, participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor.
|
Honey representing 7% of total energy (kilocalorie) needs (40-70 grams)
Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams)
Honey representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)
Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)
|
|
Experimental: Sucrose alone and sucrose with almonds, then honey alone and honey with almonds
Participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor.
After a 14 day wash-out, participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor.
|
Honey representing 7% of total energy (kilocalorie) needs (40-70 grams)
Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams)
Honey representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)
Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in postprandial glucose response
Time Frame: Measured continuously over days 0-8 and 23-31
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Interstitial glucose response measured by a continuous glucose monitor
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Measured continuously over days 0-8 and 23-31
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognitive testing for Spatial Working Memory
Time Frame: Days 4, 8, 27, and 31
|
Cambridge Neuropsychological Test Automated battery (CANTAB) software will be used to assess Spatial Working Memory (SWM)
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Days 4, 8, 27, and 31
|
|
Change in Cognitive testing for Paired Associates Learning
Time Frame: Days 4, 8, 27, and 31
|
CANTAB software will be used to assess Paired Associates Learning (PAL)
|
Days 4, 8, 27, and 31
|
|
Change in Cognitive testing for Rapid Visual Processing
Time Frame: Days 4, 8, 27, and 31
|
CANTAB software will be used to assess Rapid Visual Processing (RVP)
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Days 4, 8, 27, and 31
|
|
Change in Salivary cortisol
Time Frame: Day 0 and 23 fasting only. Days 4, 8, 27, and 31 at fasting, 30, 60 and 90 min after consumption of snack provided in standard breakfast
|
Metabolic stress will be analyzed by measuring cortisol in saliva samples
|
Day 0 and 23 fasting only. Days 4, 8, 27, and 31 at fasting, 30, 60 and 90 min after consumption of snack provided in standard breakfast
|
|
Change in Stool marker of inflammation
Time Frame: Stool collected on study days 0, 4, 8, 23, 27, and 31
|
Fecal calprotectin measured in stool samples
|
Stool collected on study days 0, 4, 8, 23, 27, and 31
|
|
Change in Stool bacterial metagenomics
Time Frame: Stool collected on study days 0, 4, 8, 23, 27, and 31
|
Honey responsive genes identified by metagenomics
|
Stool collected on study days 0, 4, 8, 23, 27, and 31
|
|
Change in Dietary Intake
Time Frame: Days 1-3, 5-7, 24-26, and 28-30
|
Food records collected using Automated Multi-pass Method (AMPM) on the platform ASA24
|
Days 1-3, 5-7, 24-26, and 28-30
|
|
Change in Self-reported hunger
Time Frame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
Responses regarding hunger will be collected using a visual analog scale on a tablet with a 0-100 scale depicting the extremes (0= not at all to 100= extremely)
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Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
|
Change in Self-reported fullness
Time Frame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
Responses regarding fullness will be collected using a visual analog scale on a tablet with a 0-100 scale depicting the extremes (0= not at all to 100= extremely)
|
Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
|
Change in Self-reported desire to eat
Time Frame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
Responses regarding desire to eat will be collected using a visual analog scale on a tablet with a 0-100 scale depicting the extremes (0= not at all to 100= extremely)
|
Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
|
Change in Self-reported satisfaction with snack
Time Frame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
Responses regarding satisfaction with snack will be collected using a visual analog scale on a tablet with a 0-100 scale depicting the extremes (0= not at all to 100= extremely)
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Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
|
Change in Self-reported prospective consumption
Time Frame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
Responses regarding prospective consumption will be collected using a visual analog scale on a tablet with a 0-100 scale depicting the extremes (0= not at all to 100= extremely)
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Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
|
Change in Self-reported nausea
Time Frame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
Responses regarding nausea will be collected using a visual analog scale on a tablet with a 0-100 scale depicting the extremes (0= not at all to 100= extremely)
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Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
|
|
Assessment of Fasted Salivary Estradiol
Time Frame: Days 0, 4, 8, 23, 27,and 31 at fasting only
|
Passive drool will be assayed for estradiol as they impact metabolic stress throughout study days
|
Days 0, 4, 8, 23, 27,and 31 at fasting only
|
|
Assessment of Fasted Salivary Progesterone
Time Frame: Days 0, 4, 8, 23, 27,and 31 at fasting only
|
Passive drool will be assayed for progesterone as they impact metabolic stress throughout study days
|
Days 0, 4, 8, 23, 27,and 31 at fasting only
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kevin Laugero, PhD, USDA, ARS, Western Human Nutrition Research Center
- Principal Investigator: Mary Kable, PhD, USDA, ARS, Western Human Nutrition Research Center
- Principal Investigator: Nancy Keim, PhD, USDA, ARS, Western Human Nutrition Research Center
Publications and helpful links
General Publications
- Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.
- Josse AR, Kendall CW, Augustin LS, Ellis PR, Jenkins DJ. Almonds and postprandial glycemia--a dose-response study. Metabolism. 2007 Mar;56(3):400-4. doi: 10.1016/j.metabol.2006.10.024.
- Gonzalez-Rodriguez M, Pazos-Couselo M, Garcia-Lopez JM, Rodriguez-Segade S, Rodriguez-Garcia J, Tunez-Bastida C, Gude F. Postprandial glycemic response in a non-diabetic adult population: the effect of nutrients is different between men and women. Nutr Metab (Lond). 2019 Jul 17;16:46. doi: 10.1186/s12986-019-0368-1. eCollection 2019.
- Gallwitz B. Implications of postprandial glucose and weight control in people with type 2 diabetes: understanding and implementing the International Diabetes Federation guidelines. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S322-5. doi: 10.2337/dc09-S331. No abstract available.
- Bach-Faig A, Berry EM, Lairon D, Reguant J, Trichopoulou A, Dernini S, Medina FX, Battino M, Belahsen R, Miranda G, Serra-Majem L; Mediterranean Diet Foundation Expert Group. Mediterranean diet pyramid today. Science and cultural updates. Public Health Nutr. 2011 Dec;14(12A):2274-84. doi: 10.1017/S1368980011002515.
- Anderson GH, Woodend D. Consumption of sugars and the regulation of short-term satiety and food intake. Am J Clin Nutr. 2003 Oct;78(4):843S-849S. doi: 10.1093/ajcn/78.4.843S.
- Tryon MS, Stanhope KL, Epel ES, Mason AE, Brown R, Medici V, Havel PJ, Laugero KD. Excessive Sugar Consumption May Be a Difficult Habit to Break: A View From the Brain and Body. J Clin Endocrinol Metab. 2015 Jun;100(6):2239-47. doi: 10.1210/jc.2014-4353. Epub 2015 Apr 16.
- Larson-Meyer DE, Willis KS, Willis LM, Austin KJ, Hart AM, Breton AB, Alexander BM. Effect of honey versus sucrose on appetite, appetite-regulating hormones, and postmeal thermogenesis. J Am Coll Nutr. 2010 Oct;29(5):482-93. doi: 10.1080/07315724.2010.10719885.
- Gourdomichali T, Papakonstantinou E. Short-term effects of six Greek honey varieties on glycemic response: a randomized clinical trial in healthy subjects. Eur J Clin Nutr. 2018 Dec;72(12):1709-1716. doi: 10.1038/s41430-018-0160-8. Epub 2018 Apr 24.
- Carroll JF, Kaiser KA, Franks SF, Deere C, Caffrey JL. Influence of BMI and gender on postprandial hormone responses. Obesity (Silver Spring). 2007 Dec;15(12):2974-83. doi: 10.1038/oby.2007.355.
- Othman Z, Shafin N, Zakaria R, Hussain NH, Mohammad WM. Improvement in immediate memory after 16 weeks of tualang honey (Agro Mas) supplement in healthy postmenopausal women. Menopause. 2011 Nov;18(11):1219-24. doi: 10.1097/gme.0b013e31821e2044.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FL118
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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