WHNRC (Western Human Nutrition Research Center) Honey Study

Study Overview
=================
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.

Official Title
-----------------
WHNRC (Western Human Nutrition Research Center) Honey Study

Conditions
-----------------
Postprandial Glycemia, Metabolic Stress, Cognitive Change, Satisfaction, Personal

Intervention / Treatment
-----------------
* Other: Honey
* Other: Sucrose
* Other: Honey plus almonds
* Other: Sucrose plus almonds


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention 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<br>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<br>* Honey representing 7% of total energy (kilocalorie) needs (40-70 grams)<br>Other: Sucrose<br>* Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams)<br>Other: Honey plus almonds<br>* Honey representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)<br>Other: Sucrose plus almonds<br>* Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)<br>|
| Experimental: Sucrose alone and sucrose with almonds, then honey alone and honey with almonds<br>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<br>* Honey representing 7% of total energy (kilocalorie) needs (40-70 grams)<br>Other: Sucrose<br>* Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams)<br>Other: Honey plus almonds<br>* Honey representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)<br>Other: Sucrose plus almonds<br>* Sucrose representing 7% of total energy (kilocalorie) needs (40-70 grams) plus 1 ounce almonds (28 grams)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postprandial glucose response | 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 Self-reported hunger | 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 | 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 | 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 | 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 | 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 | 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 | 
| Change in Cognitive testing for Spatial Working Memory | 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 | 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 | CANTAB software will be used to assess Rapid Visual Processing (RVP) | Days 4, 8, 27, and 31 | 
| Change in Salivary cortisol | 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 | Fecal calprotectin measured in stool samples | Stool collected on study days 0, 4, 8, 23, 27, and 31 | 
| Change in Stool bacterial metagenomics | Honey responsive genes identified by metagenomics | Stool collected on study days 0, 4, 8, 23, 27, and 31 | 
| Change in Dietary Intake | Food records collected using Automated Multi-pass Method (AMPM) on the platform ASA24 | Days 1-3, 5-7, 24-26, and 28-30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Satiety, Cognition, Cortisol, Glucose, Honey, Nuts, Saliva, Stool, Almonds, Sucrose