Location: Immunity and Disease Prevention Research
Project Number: 2032-10700-002-008-T
Project Type: Trust Fund Cooperative Agreement
Start Date: Sep 15, 2022
End Date: Apr 30, 2025
Objective:
Objective 1: Determine whether honey can alter postprandial glucose response in the context of a Mediterranean diet style snack containing nuts.
Objective 2: Measure satiety, cognition and metabolic stress after consumption of honey or sucrose paired with nuts.
Approach:
Aim 1 Approach:
• Design a recipe: Two versions of a Mediterranean diet style snack food recipe will be designed to incorporate sucrose with nuts (Control) or honey with nuts (Intervention). The recipe will be in the form of a spread that will be eaten directly from a scoop.
• Study Subjects: 80 adult subjects, 40 males and 40 females aged 18 – 40 years will be recruited
• Study design: Double blind, placebo controlled, cross-over design with two intervention arms of 8-day duration, separated by a 2-week wash-out period.
• Intervention: Each intervention arm will be administered in two 4-day parts. In the first part, subjects will be provided with honey (Intervention) representing 5% of total energy needs or the equivalent amount of refined sugar (Control) to consume once each day for 3 days. On Day 4 honey or sucrose combined with nuts will be provided to consume once each day for an additional 3-days.
• Endpoints:
o Food records detailing food item and time of consumption during the 8-day intervention arms for each subject. Subjects will be instructed to record the exact time of consumption for experimental snack items.
o Continuous glucose monitoring using the Abbott Freestyle Libre Pro Sensor, which provides interstitial glucose values every 15 minutes, during the 8-day intervention and control arms for each subject.
o Stool inflammatory markers (fecal calprotectin) from stool samples collected at baseline (Day -1 to 0) and post-intervention (Day 6 to 7) for each subject.
o Stool collected and stored in RNA later for a future metatranscriptomics analysis of bacterial gene expression.
Aim 2 Approach:
In the morning of the final day of each intervention period, subjects will come to the WHNRC fasted. They will each be provided with the snack food item corresponding their current intervention period in the context of a standard breakfast meal and three sets of tests will be performed.
• An acceptability and satiety questionnaire will be administered to understand the palatability of each intervention as well as the relative hunger, fullness, desire to eat, and prospective consumption experienced by subjects consuming each version of the snack food. The satiety questionnaire will be administered immediately before and after consumption of the standard breakfast with snack food, and at 30 minute intervals thereafter.
• Learning and memory will be analyzed using the Spatial Working Memory (SWM) test, Paired Associates Learning (PAL), and Rapid Visual Processing (RVP) tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB).
• Metabolic stress will be analyzed by measuring cortisol levels in the saliva of each subject. Saliva will be collected using Salimetrics reagents and devices, prior to consumption of the intervention snack food, 30 min after, and 60 min after consumption of the snack food.