Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods
NCT Number: NCT06508424
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glycaemic Response|Appetitive Behavior|Energy Intake
Interventions: OTHER: PulseOn|OTHER: Wheat flour control
Sponsor: Sheffield Hallam University
Collaborators: Quadram Institute Bioscience|Biotechnology and Biological Sciences Research Council
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07
Completion Date: 2024-11
Locations: Food and Nutrition Group, Sheffield Hallam University, Sheffield, South Yorkshire, S1 1WB, United Kingdom

Summary:
The purpose of this randomised control trial is to determine whether consuming PulseOn enriched crackers for breakfast influences post-prandial glycaemic response and markers of appetite (hunger, fullness, desire to eat) over 4 hours, and energy intake at an ad libitum lunch meal on the same day. Healthy individuals with no underlying metabolic disease will be recruited to take part in this study.

Primary Outcome Measures: Energy Intake at a test meal, Following the consumption of either the control / PulseOn enriched preload (crackers), participants will be asked to consume a standardised lunch meal of pasta and tomato sauce until they are full. The amount consumed will be measured using the Sussex Ingestion Pattern Monitor, and reported in grams and kcals., Participants consume the preload at 0 minutes, and the test meal at 240mins.|Glycaemic response, Following the consumption of either the control / PulseOn enriched preload (crackers), capillary blood samples will be measured at 15 / 30 minute intervals up to lunch time., Baseline blood measures to be taken at -30 minutes. Participants consume the preload at 0 minutes, and capillary blood samples are measured at 30, 45, 60, 75, 90, 105, 120, 150, 180 and 210 minutes.|Markers of appetite, Following the consumption of either the control / PulseOn enriched preload (crackers), hunger, fullness and desire to eat will be measured at 15 / 30 minute intervals up to lunch time using visual analogue scale., Baseline hunger, fullness and desire to eat to be taken at -30 minutes. Participants consume the preload at 0 minutes, and further hunger, fullness and desire to eat measures are taken at 30, 45, 60, 75, 90, 105, 120, 150, 180 and 210 minutes.
Secondary Outcome Measures: Mood, Following the consumption of either the control / PulseOn enriched preload (crackers), the following attributes will be measured at 15 / 30 minute intervals up to lunch time using visual analogue scale - happy, relaxed, energetic, thirsty, nauseous., Baseline mood ratings will be measured at -30 minutes. Participants consume the preload at 0 minutes, and further mood ratings are measured at 30, 45, 60, 75, 90, 105, 120, 150, 180 and 210 minutes.|Post intervention food / energy / nutrient intake, Following the completion of the lab-based study, participants will leave the research facility and complete a 24hr estimated measures diet diary which will be analysed on Nutritics., 24hrs post intervention