Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508424
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Investigating the Glycaemic and Satiating Capacity of PulseOn Enriched Foods
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Glycaemic and Satiating Capacity of PulseOn Enriched Foods a Randomised Control Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 kgm2 waist circumference cm blood glucose mmoll 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
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 kgm2 waist circumference cm blood glucose mmoll 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None