WHNRC (Western Human Nutrition Research Center) Honey Study

Cognitive Change Clinical Trial

Official title:

WHNRC (Western Human Nutrition Research Center) Honey Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107231
• Other study ID #: FL118
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2024
• Source: USDA, Western Human Nutrition Research Center
• Contact: Ellen Bonnel, PhD
• Phone: (530)752-4184
• Email: ellen.bonnel[@]usda.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2026
• Est. primary completion date: January 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Metabolic Stress
• Postprandial Glycemia
• Satisfaction, Personal

Intervention

Other:
• Honey
Honey representing 7% of total energy (kilocalorie) needs (40-70 grams)
• Sucrose
Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams)
• Honey plus almonds
Honey representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)
• Sucrose plus almonds
Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)

Locations

Country	Name	City	State
United States	USDA, ARS, Western Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	National Honey Board

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Menopause. 2012 Mar;19(3):377. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postprandial glucose response	Interstitial glucose response measured by a continuous glucose monitor	Measured continuously over days 0-8 and 23-31
Secondary	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
Secondary	Change in Self-reported fullness	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Stool marker of inflammation	Fecal calprotectin measured in stool samples	Stool collected on study days 0, 4, 8, 23, 27, and 31
Secondary	Change in Stool bacterial metagenomics	Honey responsive genes identified by metagenomics	Stool collected on study days 0, 4, 8, 23, 27, and 31
Secondary	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

External Links

•   CDC National Diabetes Statistics Report, 2020, Estimates of Diabetes and Its Burden in the United States