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NCT Number: NCT06508424

Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods

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.

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Key information

Conditions

Glycaemic Response Appetitive Behavior Behavior Behavior, Animal Energy Intake

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food and Nutrition Group, Sheffield Hallam University

Sheffield, South Yorkshire, S1 1WB, United Kingdom

Location status: Recruiting

About 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PulseOn

Other

PulseOn - 1 week washout period between interventions 75g crackers

Wheat flour control

Other

Control -1 week washout period between interventions 75g crackers

Other names: Wheat flour

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • Biotechnology and Biological Sciences Research Council
  • Quadram Institute Bioscience

Registry information

Official study title

Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods: a Randomised Control Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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