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WHNRC (Western Human Nutrition Research Center) Honey Study

Not Applicable
Recruiting
Conditions
Satisfaction, Personal
Postprandial Glycemia
Cognitive Change
Metabolic Stress
Interventions
Other: Honey
Other: Sucrose
Other: Honey plus almonds
Other: Sucrose plus almonds
Registration Number
NCT06107231
Lead Sponsor
USDA, Western Human Nutrition Research Center
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
80
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

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Honey alone and honey with almonds, then sucrose alone and sucrose with almondsHoneyParticipants 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 alone and honey with almonds, then sucrose alone and sucrose with almondsSucrose plus almondsParticipants 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.
Sucrose alone and sucrose with almonds, then honey alone and honey with almondsHoneyParticipants 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 alone and honey with almonds, then sucrose alone and sucrose with almondsHoney plus almondsParticipants 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 alone and honey with almonds, then sucrose alone and sucrose with almondsSucroseParticipants 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.
Sucrose alone and sucrose with almonds, then honey alone and honey with almondsSucroseParticipants 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.
Sucrose alone and sucrose with almonds, then honey alone and honey with almondsHoney plus almondsParticipants 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.
Sucrose alone and sucrose with almonds, then honey alone and honey with almondsSucrose plus almondsParticipants 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.
Primary Outcome Measures
NameTimeMethod
Change in postprandial glucose responseMeasured continuously over days 0-8 and 23-31

Interstitial glucose response measured by a continuous glucose monitor

Secondary Outcome Measures
NameTimeMethod
Change in Self-reported nauseaFasting 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)

Change in Self-reported hungerFasting 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)

Change in Self-reported fullnessFasting 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)

Change in Self-reported desire to eatFasting 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)

Change in Self-reported satisfaction with snackFasting 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)

Change in Cognitive testing for Paired Associates LearningDays 4, 8, 27, and 31

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

Change in Salivary cortisolDay 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

Change in Self-reported prospective consumptionFasting 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)

Change in Cognitive testing for Spatial Working MemoryDays 4, 8, 27, and 31

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

Change in Cognitive testing for Rapid Visual ProcessingDays 4, 8, 27, and 31

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

Change in Stool marker of inflammationStool collected on study days 0, 4, 8, 23, 27, and 31

Fecal calprotectin measured in stool samples

Assessment of Fasted Salivary EstradiolDays 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

Assessment of Fasted Salivary ProgesteroneDays 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

Change in Dietary IntakeDays 1-3, 5-7, 24-26, and 28-30

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

Change in Stool bacterial metagenomicsStool collected on study days 0, 4, 8, 23, 27, and 31

Honey responsive genes identified by metagenomics

Trial Locations

Locations (1)

USDA, ARS, Western Human Nutrition Research Center

🇺🇸

Davis, California, United States

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