Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06107231
Other study ID # FL118
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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 allClick 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
See also
  Status Clinical Trial Phase
Completed NCT05712005 - Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study
Completed NCT05343208 - Effectiveness of Online Therapy to Prevent Burnout N/A
Active, not recruiting NCT05143294 - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT05267730 - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT03987477 - Online Intervention to Modify Interpretation Biases in Depression N/A
Completed NCT03695003 - Cognitive Effects of Sage in Healthy Humans N/A
Completed NCT05075850 - Multicenter Sub-study for LAANTERN Registry NCT02392078 That Will Include Comprehensive Neuropsychological Assessment Data Collection
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT03674281 - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System N/A
Completed NCT03689348 - Acute and Chronic Effects of Avena Sativa on Cognition and Stress N/A
Active, not recruiting NCT05229705 - Exercise in Older Adults at Risk for Type 2 Diabetes N/A
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Completed NCT03657537 - Effects of Ketone Bodies on Cognition in Type 2 Diabetes Phase 1
Completed NCT05543811 - The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Pathology N/A
Recruiting NCT05699226 - Amplitude Titration to Improve ECT Clinical Outcomes N/A
Recruiting NCT05026541 - Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators N/A
Active, not recruiting NCT03255499 - Efficacy of the MovinCog Intervention in Children N/A
Not yet recruiting NCT06252376 - Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD N/A