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

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

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Davis, California, United States, 95616
        • USDA, ARS, Western Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Interstitial glucose response measured by a continuous glucose monitor
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)
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)
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)
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)
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)
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)
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Actual)

October 31, 2025

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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