WHNRC (Western Human Nutrition Research Center) Honey Study

Sponsor
USDA, Western Human Nutrition Research Center (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT06107231
Collaborator
National Honey Board (Other)
80
1
2
25
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Honey
  • Other: Sucrose
  • Other: Honey plus almonds
  • Other: Sucrose plus almonds
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
WHNRC (Western Human Nutrition Research Center) Honey Study
Anticipated Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Nov 30, 2025

Arms and Interventions

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.

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

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

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

Other: Sucrose plus almonds
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.

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in postprandial glucose response [Measured continuously over days 0-8 and 23-31]

    Interstitial glucose response measured by a continuous glucose monitor

Secondary Outcome Measures

  1. Change in Self-reported hunger [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)

  2. Change in Self-reported fullness [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)

  3. 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]

    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)

  4. 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]

    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)

  5. 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]

    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)

  6. Change in Self-reported nausea [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)

  7. Change in Cognitive testing for Spatial Working Memory [Days 4, 8, 27, and 31]

    Cambridge Neuropsychological Test Automated battery (CANTAB) software will be used to assess Spatial Working Memory (SWM)

  8. Change in Cognitive testing for Paired Associates Learning [Days 4, 8, 27, and 31]

    CANTAB software will be used to assess Paired Associates Learning (PAL)

  9. Change in Cognitive testing for Rapid Visual Processing [Days 4, 8, 27, and 31]

    CANTAB software will be used to assess Rapid Visual Processing (RVP)

  10. Change in Salivary cortisol [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

  11. Change in Stool marker of inflammation [Stool collected on study days 0, 4, 8, 23, 27, and 31]

    Fecal calprotectin measured in stool samples

  12. Change in Stool bacterial metagenomics [Stool collected on study days 0, 4, 8, 23, 27, and 31]

    Honey responsive genes identified by metagenomics

  13. Change in Dietary Intake [Days 1-3, 5-7, 24-26, and 28-30]

    Food records collected using Automated Multi-pass Method (AMPM) on the platform ASA24

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 USDA, ARS, Western Human Nutrition Research Center Davis California United States 95616

Sponsors and Collaborators

  • USDA, Western Human Nutrition Research Center
  • National Honey Board

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT06107231
Other Study ID Numbers:
  • FL118
First Posted:
Oct 30, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
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
Keywords provided by USDA, Western Human Nutrition Research Center

Study Results

No Results Posted as of Nov 2, 2023