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| Name | Class |
|---|---|
| National Honey Board | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Honey alone and honey with almonds, then sucrose alone and sucrose with almonds | Experimental | 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. |
|
| Sucrose alone and sucrose with almonds, then honey alone and honey with almonds | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honey | Other | Honey representing 7% of total energy (kilocalorie) needs (40-70 grams) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in postprandial glucose response | Interstitial glucose response measured by a continuous glucose monitor | Measured continuously over days 0-8 and 23-31 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-reported hunger | 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) | Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31 |
| Change in Self-reported fullness |
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Inclusion Criteria:
Exclusion Criteria:
Regarding female candidates:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Kable, PhD | USDA, ARS, Western Human Nutrition Research Center | Principal Investigator |
| Nancy Keim, PhD | USDA, ARS, Western Human Nutrition Research Center | Principal Investigator |
| Kevin Laugero, PhD | USDA, ARS, Western Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA, ARS, Western Human Nutrition Research Center | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14522748 | Background | 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. | |
| 25879513 | Background | 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. |
| Label | URL |
|---|---|
| CDC National Diabetes Statistics Report, 2020, Estimates of Diabetes and Its Burden in the United States | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 7, 2025 | Nov 18, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D006722 | Honey |
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Sucrose | Other | Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams) |
|
| Honey plus almonds | Other | Honey representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams) |
|
| Sucrose plus almonds | Other | Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams) |
|
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 | 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 | 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) | 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 | 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) | Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31 |
| Change in Self-reported nausea | 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) | Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31 |
| Change in Cognitive testing for Spatial Working Memory | Cambridge Neuropsychological Test Automated battery (CANTAB) software will be used to assess Spatial Working Memory (SWM) | Days 4, 8, 27, and 31 |
| Change in Cognitive testing for Paired Associates Learning | 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 | CANTAB software will be used to assess Rapid Visual Processing (RVP) | Days 4, 8, 27, and 31 |
| Change in Salivary cortisol | 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 |
| Assessment of Fasted Salivary Estradiol | 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 | 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 |
| Change in Stool marker of inflammation | Fecal calprotectin measured in stool samples | Stool collected on study days 0, 4, 8, 23, 27, and 31 |
| Change in Stool bacterial metagenomics | Honey responsive genes identified by metagenomics | Stool collected on study days 0, 4, 8, 23, 27, and 31 |
| Change in Dietary Intake | Food records collected using Automated Multi-pass Method (AMPM) on the platform ASA24 | Days 1-3, 5-7, 24-26, and 28-30 |
| 31992061 | Background | 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. |
| 19875573 | Background | 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. |
| 22166184 | Background | 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. |
| 17292730 | Background | 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. |
| 21504975 | Background | 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. |
| 29686412 | Background | 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. |
| 21926932 | Background | 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. |
| 31346341 | Background | 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. |
| 18198306 | Background | 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. |
| D004187 |
| Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |