Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods

July 12, 2024 updated by: Anna Sorsby, Sheffield Hallam University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S1 1WB
        • Recruiting
        • Food and Nutrition Group, Sheffield Hallam University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PulseOn enriched crackers
Other: PulseOn
PulseOn - 1 week washout period between interventions 75g crackers
Placebo Comparator: Wheat Flour Control
Other: Wheat flour control
Control -1 week washout period between interventions 75g crackers
Other Names:
  • Wheat flour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants consume the preload at 0 minutes, and the test meal at 240mins.
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.
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
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.
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

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 24hrs post intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Hallam University

Collaborators

Biotechnology and Biological Sciences Research Council
Quadram Institute Bioscience

Investigators

  • Principal Investigator: Caroline E Millman, PhD, Sheffield Hallam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ER64439232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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