Clinical trial NCT06107231: WHNRC (Western Human Nutrition Research Center) Honey Study
Official title: WHNRC (Western Human Nutrition Research Center) Honey Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postprandial Glycemia
Metabolic Stress
Cognitive Change
Satisfaction, Personal
Keywords: Satiety
Cognition
Cortisol
Glucose
Honey
Nuts
Saliva
Stool
Almonds
Sucrose
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: National Honey Board
First posted: 2023-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in postprandial glucose response
timeFrame: Measured continuously over days 0-8 and 23-31
Secondary outcomes:
measure: Change in Self-reported hunger
timeFrame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
measure: Change in Self-reported fullness
timeFrame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
measure: Change in Self-reported desire to eat
timeFrame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
measure: Change in Self-reported satisfaction with snack
timeFrame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
measure: Change in Self-reported prospective consumption
timeFrame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
measure: Change in Self-reported nausea
timeFrame: Fasting and 30, 60, and 90 min after consumption of standard breakfast on days 4, 8, 27, and 31
measure: Change in Cognitive testing for Spatial Working Memory
timeFrame: Days 4, 8, 27, and 31
measure: Change in Cognitive testing for Paired Associates Learning
timeFrame: Days 4, 8, 27, and 31
measure: Change in Cognitive testing for Rapid Visual Processing
timeFrame: Days 4, 8, 27, and 31
measure: Change in Salivary cortisol
timeFrame: 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
measure: Assessment of Fasted Salivary Estradiol
timeFrame: Days 0, 4, 8, 23, 27,and 31 at fasting only
measure: Assessment of Fasted Salivary Progesterone
timeFrame: Days 0, 4, 8, 23, 27,and 31 at fasting only
measure: Change in Stool marker of inflammation
timeFrame: Stool collected on study days 0, 4, 8, 23, 27, and 31
measure: Change in Stool bacterial metagenomics
timeFrame: Stool collected on study days 0, 4, 8, 23, 27, and 31
measure: Change in Dietary Intake
timeFrame: Days 1-3, 5-7, 24-26, and 28-30
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Mary Kable, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Nancy Keim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Kevin Laugero, PhD
role: PRINCIPAL_INVESTIGATOR
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