Glycaemic ResponseNCT06508424
Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods
A study testing PulseOn in people with Glycaemic Response and Appetitive Behavior, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycaemic Response, Appetitive Behavior, Energy Intake
- What is being tested?
- PulseOn
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 18y
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Food and Nutrition Group, Sheffield Hallam University
Sheffield, South Yorkshire, S1 1WB
Anna C Sorsby, MSc, 01142256279 ext. 6279, a.sorsby@shu.ac.uk
Caroline E Millman, PhD, 01142256871 ext. 6871, c.e.millman@shu.ac.uk
About this study
Official title: 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.
Read the 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 (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
- Glycaemic Response, Appetitive Behavior, Energy Intake
- Being tested
- PulseOn, Wheat flour control
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseOnOther
PulseOn - 1 week washout period between interventions 75g crackers
Wheat flour controlOther
Also called Wheat flour
Control -1 week washout period between interventions 75g crackers
| Study group | Role | What they receive |
|---|---|---|
| PulseOn enriched crackers | Experimental | PulseOn enriched crackers Receives: Other: PulseOn |
| Wheat Flour Control | Placebo comparator | Wheat Flour Control Receives: Other: Wheat flour control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 outcomes (2)
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.
Measured: 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.
Measured: 24hrs post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glycaemic ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience, Biotechnology and Biological Sciences Research Council
- Responsible party
- Principal investigator, Anna Sorsby, Sheffield Hallam University
- Investigators
- Caroline E Millman, PhD, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508424
- Sponsor's protocol ID
- ER64439232
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 32140680Bajka 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.
PubMed 33941996Bajka 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.
PubMed 36811474Palchen 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.
PubMed 35761557Alshaalan 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.
PubMed 38823849
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06508424
- Acronym / sponsor ID
- ER64439232
- Conditions
- Glycaemic Response, Appetitive Behavior, Energy Intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience, Biotechnology and Biological Sciences Research Council
- Study start
- Jul 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PulseOn enriched crackers | Experimental | Other: PulseOnPulseOn enriched crackers |
| Wheat Flour Control | Placebo comparator | Other: Wheat flour controlWheat Flour Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over the age of 18y
Key exclusion criteria (12 listed)
- smoker / recreational drug user
- restrained eater (as determined by the three factor eating questionnaire (TFEQ-R18))
- vegan
- pregnant / lactating
- blood clotting disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PulseOnPulseOn - 1 week washout period between interventions 75g crackers | Other | PulseOn enriched crackers |
| Wheat flour controlAlso: Wheat flourControl -1 week washout period between interventions 75g crackers | Other | Wheat Flour Control |
Primary outcome
Energy Intake at a test meal
Time frame: Participants consume the preload at 0 minutes, and the test meal at 240mins.
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.
Glycaemic response
Time frame: 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.
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.
Markers of appetite
Time frame: 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.
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.
2 secondary outcomes
Mood
Time frame: 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
Time frame: 24hrs post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- BackgroundEdwards, 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.
- Background: PubMed 32140680Delamare 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.
- Background: PubMed 33941996Bajka 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.
- Background: PubMed 36811474Bajka 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.
- Background: PubMed 35761557Palchen 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.
- Background: PubMed 38823849Alshaalan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline E Millman, PhD principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PulseOn in people with Glycaemic Response and Appetitive Behavior, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna C Sorsby, MSc (01142256279 ext. 6279, a.sorsby@shu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Intake at a test meal (time frame: Participants consume the preload at 0 minutes, and the test meal at 240mins.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508424, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.