Investigating the Glycaemic and Satiating Capacity of PulseOn® Enriched Foods

NCT06508424 | Recruiting

• 1 other identifier: ER64439232
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. Healthy individuals with no underlying metabolic disease will be recruited to take part in this study.

Conditions

Glycaemic Response; Appetitive Behavior; Energy Intake

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  24hrs post intervention

Study Arms (2)

PulseOn enriched crackers

EXPERIMENTAL

PulseOn enriched crackers

Other: PulseOn

Wheat Flour Control

PLACEBO COMPARATOR

Wheat Flour Control

Other: Wheat flour control

Interventions

PulseOn OTHER

PulseOn - 1 week washout period between interventions 75g crackers

PulseOn enriched crackers

Wheat flour control OTHER

Control -1 week washout period between interventions 75g crackers

Also known as: Wheat flour

Wheat Flour Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over the age of 18y

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Quadram Institute Bioscience: collaborator
• Biotechnology and Biological Sciences Research Council: collaborator

Study Sites (1)

Food and Nutrition Group, Sheffield Hallam University

Sheffield, South Yorkshire, S1 1WB, United Kingdom

RECRUITING

Related Publications (6)

• 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.

  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.

  PMID: 32140680 BACKGROUND

• 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.

  PMID: 33941996 BACKGROUND

• 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.

  PMID: 36811474 BACKGROUND

• 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.

  PMID: 35761557 BACKGROUND

• 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.

  PMID: 38823849 BACKGROUND

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Flour

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Caroline E Millman, PhD

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna C Sorsby, MSc

CONTACT

01142256279; a.sorsby@shu.ac.uk

Caroline E Millman, PhD

CONTACT

01142256871; c.e.millman@shu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Nutrition

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)