Health TrialsbyHealthPanel

Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods

ConditionsGlycaemic ResponseAppetitive BehaviorEnergy Intake
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSheffield Hallam University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

over the age of 18y

Disqualifiers

smoker / recreational drug user

restrained eater (as determined by the three factor eating questionnaire (TFEQ-R18))

vegan

pregnant / lactating

Trial design

Design model

Crossover

Treatments tested in this trial

  • PulseOn

    Other intervention

    PulseOn - 1 week washout period between interventions 75g crackers

  • Wheat flour control

    Other intervention

    Control -1 week washout period between interventions 75g crackers

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PulseOn enriched crackersExperimental treatment 1 intervention
Group B: Wheat Flour ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Participants consume the preload at 0 minutes, and the test meal at 240mins.
2

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.

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.
3

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.

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.

Secondary outcomes

1

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.

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.
2

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.

Time frame
24hrs post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheffield Hallam University

Lead sponsor

Quadram Institute Bioscience

Collaborator

Biotechnology and Biological Sciences Research Council

Collaborator

Source ClinicalTrials.gov
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