Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods

NCT ID: NCT06508424

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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Glycaemic Response Appetitive Behavior Energy Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomly assigned to either the treatment (PulseOn) or control group at the outset of their participation. Following a minimum of a one-week washout period, participants will then participate in the alternative arm.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will not be told which arm of the trial they are taking part in. PulseOn crackers and the wheat flour control crackers have been matched as closely as possible for energy content and sensory characteristics. Participants will be asked to rate the acceptability of the crackers to determine whether there are any discernible differences, however they are required to consume a set amount.

Study Groups

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PulseOn enriched crackers

PulseOn enriched crackers

Group Type EXPERIMENTAL

PulseOn

Intervention Type OTHER

PulseOn - 1 week washout period between interventions 75g crackers

Wheat Flour Control

Wheat Flour Control

Group Type PLACEBO_COMPARATOR

Wheat flour control

Intervention Type OTHER

Control -1 week washout period between interventions 75g crackers

Interventions

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PulseOn

PulseOn - 1 week washout period between interventions 75g crackers

Intervention Type OTHER

Wheat flour control

Control -1 week washout period between interventions 75g crackers

Intervention Type OTHER

Other Intervention Names

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Wheat flour

Eligibility Criteria

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Inclusion Criteria

* over the age of 18y

Exclusion Criteria

* smoker / recreational drug user
* restrained eater (as determined by the three factor eating questionnaire (TFEQ-R18))
* vegan
* pregnant / lactating
* blood clotting disorder
* taking medication for heart / metabolic disease
* pacemaker fitted
* energy restricted diet or lost \>5% body weight in the last 3 months
* elite athletes
* dysphagia
* food allergy / intolerance
* disease / inflammation of the GI tract
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quadram Institute Bioscience

OTHER

Sponsor Role collaborator

Biotechnology and Biological Sciences Research Council

OTHER

Sponsor Role collaborator

Sheffield Hallam University

OTHER

Sponsor Role lead

Responsible Party

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Anna Sorsby

Senior Lecturer in Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caroline E Millman, PhD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Hallam University

Locations

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Food and Nutrition Group, Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Anna C Sorsby, MSc

Role: CONTACT

01142256279 ext. 6279

Caroline E Millman, PhD

Role: CONTACT

01142256871 ext. 9871

Facility Contacts

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Anna C Sorsby, MSc

Role: primary

01142256279 ext. 6279

Caroline E Millman, PhD

Role: backup

01142256871 ext. 6871

References

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Edwards, C. H., Ryden, P., Pinto, A. M., van Der Schoot, A., Stocchi, C., Perez-Moral, N., ... & Ellis, P. R. (2020). Chemical, physical and glycaemic characterisation of PulseON®: A novel legume cell-powder ingredient for use in the design of functional foods. Journal of Functional Foods, 68, 103918.

Reference Type BACKGROUND

Delamare GYF, Butterworth PJ, Ellis PR, Hill S, Warren FJ, Edwards CH. Incorporation of a novel leguminous ingredient into savoury biscuits reduces their starch digestibility: Implications for lowering the Glycaemic Index of cereal products. Food Chem X. 2020 Feb 7;5:100078. doi: 10.1016/j.fochx.2020.100078. eCollection 2020 Mar 30.

Reference Type BACKGROUND
PMID: 32140680 (View on PubMed)

Bajka BH, Pinto AM, Ahn-Jarvis J, Ryden P, Perez-Moral N, van der Schoot A, Stocchi C, Bland C, Berry SE, Ellis PR, Edwards CH. The impact of replacing wheat flour with cellular legume powder on starch bioaccessibility, glycaemic response and bread roll quality: A double-blind randomised controlled trial in healthy participants. Food Hydrocoll. 2021 May;114:106565. doi: 10.1016/j.foodhyd.2020.106565.

Reference Type BACKGROUND
PMID: 33941996 (View on PubMed)

Bajka BH, Pinto AM, Perez-Moral N, Saha S, Ryden P, Ahn-Jarvis J, van der Schoot A, Bland C, Berry SE, Ellis PR, Edwards CH. Enhanced secretion of satiety-promoting gut hormones in healthy humans after consumption of white bread enriched with cellular chickpea flour: A randomized crossover study. Am J Clin Nutr. 2023 Mar;117(3):477-489. doi: 10.1016/j.ajcnut.2022.12.008. Epub 2022 Dec 28.

Reference Type BACKGROUND
PMID: 36811474 (View on PubMed)

Palchen K, Bredie WLP, Duijsens D, Isaac Alfie Castillo A, Hendrickx M, Van Loey A, Raben A, Grauwet T. Effect of processing and microstructural properties of chickpea-flours on in vitro digestion and appetite sensations. Food Res Int. 2022 Jul;157:111245. doi: 10.1016/j.foodres.2022.111245. Epub 2022 Apr 12.

Reference Type BACKGROUND
PMID: 35761557 (View on PubMed)

Alshaalan RA, Charalambides MN, Edwards CH, Ellis PR, Alrabeah SH, Frost GS. Impact of chickpea hummus on postprandial blood glucose, insulin and gut hormones in healthy humans combined with mechanistic studies of food structure, rheology and digestion kinetics. Food Res Int. 2024 Jul;188:114517. doi: 10.1016/j.foodres.2024.114517. Epub 2024 May 10.

Reference Type BACKGROUND
PMID: 38823849 (View on PubMed)

Other Identifiers

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ER64439232

Identifier Type: -

Identifier Source: org_study_id

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