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Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods: a Randomised Control Trial
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.
PulseON® is a unique flour that is made 100% from pulses, but unlike other flours it has been obtained through an alternative milling process (WO2019155190) which preserves whole plant cells (Edwards et al., 2020). These cells were shown to remain intact during down-stream processing into food products including bread and biscuits, and influence glycaemic response to these foods (Delamare et al., 2020; Bajka et al., 2021). Interestingly, the PulseON®-enriched breads also significantly enhanced and prolonged release of the gut hormones glucagon-like peptide-1 (GLP1) and peptide YY (PYY), which are known to have anorexigenic effects (Bajka et al., 2023). Studies using chick pea purees and hummus products have also shown positive findings in relation to appetite sensations and food intake (Pälchen et al., 2022; Alshaalan et al., 2024). This work aims to recruit 50 participants through the use of posters and emails at Sheffield Hallam University, as well as in the local Sheffield area and through social media. -30 minutes - baseline measures (body mass index (kg/m2), waist circumference (cm), blood glucose (mmol/l), hunger, fullness, desire to eat) are taken 0 minutes - pre-load consumed within 15 minutes (75g wheat flour / PulseOn crackers) The wheat flour cracker is made from 100% wheat flour. The PulseOn cracker is made from 40% PulseOn flour and 60% wheat flour. 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 minutes - repeat baseline measures 240 minutes - ad libitum lunch provided (pasta and tomato sauce) and participants instructed to eat to fullness. Paired sample t-tests will be used to compare measures between the two visits.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Food and Nutrition Group, Sheffield Hallam University
Sheffield, South Yorkshire, United Kingdom
Start Date
July 1, 2024
Primary Completion Date
November 1, 2024
Completion Date
November 1, 2024
Last Updated
July 18, 2024
50
ESTIMATED participants
PulseOn
OTHER
Wheat flour control
OTHER
Lead Sponsor
Sheffield Hallam University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06757608