NCT06107231

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2024Oct 2026

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 16, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Expected
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

October 24, 2023

Last Update Submit

November 18, 2025

Conditions

Keywords

SatietyCognitionCortisolGlucoseHoneyNutsSalivaStoolAlmondsSucrose

Outcome Measures

Primary Outcomes (1)

  • Change in postprandial glucose response

    Interstitial glucose response measured by a continuous glucose monitor

    Measured continuously over days 0-8 and 23-31

Secondary Outcomes (15)

  • Change in Self-reported hunger

    Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31

  • Change in Self-reported fullness

    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

    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

    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

    Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31

  • +10 more secondary outcomes

Study Arms (2)

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.

Other: HoneyOther: SucroseOther: Honey plus almondsOther: Sucrose plus almonds

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.

Other: HoneyOther: SucroseOther: Honey plus almondsOther: Sucrose plus almonds

Interventions

HoneyOTHER

Honey representing 7% of total energy (kilocalorie) needs (40-70 grams)

Honey alone and honey with almonds, then sucrose alone and sucrose with almondsSucrose alone and sucrose with almonds, then honey alone and honey with almonds
SucroseOTHER

Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams)

Honey alone and honey with almonds, then sucrose alone and sucrose with almondsSucrose alone and sucrose with almonds, then honey alone and honey with almonds

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

Honey alone and honey with almonds, then sucrose alone and sucrose with almondsSucrose alone and sucrose with almonds, then honey alone and honey with almonds

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

Honey alone and honey with almonds, then sucrose alone and sucrose with almondsSucrose alone and sucrose with almonds, then honey alone and honey with almonds

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women must be pre-menopausal
  • Willing to consume snacks that contain honey, table sugar, and tree nuts

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related 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.

    PMID: 14522748BACKGROUND
  • 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.

    PMID: 25879513BACKGROUND
  • 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.

    PMID: 31992061BACKGROUND
  • 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.

    PMID: 19875573BACKGROUND
  • 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.

    PMID: 22166184BACKGROUND
  • 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.

    PMID: 17292730BACKGROUND
  • 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.

    PMID: 21504975BACKGROUND
  • 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.

    PMID: 29686412BACKGROUND
  • 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.

    PMID: 21926932BACKGROUND
  • 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.

    PMID: 31346341BACKGROUND
  • 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.

    PMID: 18198306BACKGROUND

Related Links

MeSH Terms

Conditions

Personal Satisfaction

Interventions

HoneySucrose

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

January 16, 2024

Primary Completion

October 31, 2025

Study Completion (Estimated)

October 30, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations