ISRCTN ISRCTN67732674
DOI https://doi.org/10.1186/ISRCTN67732674
Secondary identifying numbers RG.PSYC.118567
Submission date
11/12/2023
Registration date
05/03/2024
Last edited
16/02/2024
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Currently, there is no reference system relating the properties of foods to measure satiety or how consumers experience or perceive the satiating properties of different foods. This project aims to understand appetitive responses to a set of representative foods. This project will link objective measures of food composition and satiety to self-report food perceptions, appetitive traits, and food intake.

Who can participate?
Healthy adult volunteers aged 18 years old and over

What does the study involve?
This project will recruit participants to complete an online survey, followed by laboratory visits on two occasions. At the laboratory visits participants will be required to consume either a control food (bread) or a test food, which will be randomly selected and will be presented in 240 kcal portions. Over the next 2 hours, appetitive responses will be assessed with questionnaires. At the end of the visit, subjects will be provided with an ad-libitum meal to assess energy intake.

What are the possible benefits and risks of participating?
Benefits of participating include £25 per participant for completion of the study. There is a risk of allergic reactions to the study foods. Therefore, the study will not recruit anyone who reports an allergy to any ingredient of any of the study foods.

Where is the study run from?
University of Leeds (UK)

When is the study starting and how long is it expected to run for?
April 2022 to June 2025

Who is funding the study?
Slimming World UK (UK)

Who is the main contact?
Professor James Stubbs, r.j.stubbs@leeds.ac.uk (UK)

Contact information

Prof R James Stubbs
Public, Scientific, Principal Investigator

School of Psychology
Faculty of Medicine and Health
University of Leeds
Leeds
LS2 9JT
United Kingdom

ORCiD logoORCID ID 0000-0002-0843-9064
Phone +44 (0)113 343 3476
Email r.j.stubbs@leeds.ac.uk

Study information

Study designWithin and between subject comparison intervention of the satiating effect of different foods
Primary study designInterventional
Secondary study designRandomized counterbalanced allocation
Study setting(s)Internet/virtual, University/medical school/dental school
Study typeEfficacy
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleObjectively measured satiety of 36 food preload foods that are representative of the nutritional properties of the UK diet in UK 444 adults - The SatMap Project
Study acronymSatMap
Study hypothesisThis project aims to understand appetitive responses to a set of representative foods. This project will link objective measures of food composition and satiety to self-report food perceptions, appetitive traits, and food intake.

Hypothesis 1: That the macronutrient composition and energy density of foods explain differences in measured satiety in response to eating different foods.
Ethics approval(s)

Approved 25/05/2023, University of Leeds, School of Psychology Ethics Committee (School of Psychology, Faculty of Medicine and Health, Leeds, LS2 9JT, United Kingdom; +44 (0)113 3437601; psyc-ethicssubmissions@leeds.ac.uk), ref: PSYC-PSYC-524

ConditionThe satiating effect of different foods in healthy participants
InterventionThe study is a laboratory-based experimental design, with online questionnaire assessments. Participants will be required to fill in several physiological and psychological measures online and attend the Human Appetite Research Unit (HARU) at the University of Leeds in person for a minimum of 2 separate visits. The visits are test days that involve a control preload on one day and a randomly selected test preload on another day, which can be conducted over 3 months. Randomisation is performed between subjects for intervention versus control in a counterbalanced order. The rationale for the inclusion of a control food (bread) for all participants is that the bread will act as a standard comparator to allow the normalisation of VAS scores for all participants. Throughout the test days, the participants will fill in visual analogue scales (VAS) measuring appetite sensations and the Leeds Food Preference Questionnaire (LFPQ) measuring food preferences and rewards. At 120 minutes after each of the meals, an ad libitum test meal (provided by Slimming World, [food TBC]) will be given to the participants.

Each participant receives 240 kcal of bread versus 240 kcal of test food. Researchers on the project are PhD-level investigators trained in Good Clinical Practice and Good Laboratory Practice.

The Leeds Food Preference Questionnaire (LFPQ) is used to assess food hedonics, which measures implicit and explicit wanting for high-fat (>50% energy) and low-fat (<20% energy) foods matched for familiarity, sweetness, protein, and acceptability. Implicit wanting will be assessed by asking the participants to choose as quickly as possible which food from specific categories “they most want to eat”. Scores are computed from mean response times, adjusted for frequency. Explicit liking is measured by asking participants to rate on a Visual Analog Scale (VAS)  the extent to which they like each high-fat or low-fat food presented. Low-fat scores are subtracted from high-fat scores; so that a positive score demonstrates greater implicit wanting or explicit wanting towards high-fat compared to low-fat foods. 

The method of randomisation was quasi-randomly assigning of subjects to preload, which used the total number of preloads given to the previous subject and the foods the current subject is willing to eat. A sampling algorithm was used (see https://colab.research.google.com/drive/1e3ZNk1T8flvnRsaM2Wc7fQWUPjc28MXR#scrollTo=_ALS1nvsb2Xg).
Intervention typeOther
Primary outcome measureMotivation to eat measured using a Visual Analogue Scale (VAS) at -10, -5, 10, 20, 30, 60, 90, and 120 minutes post-ingestion
Secondary outcome measures1. Energy intake at a standardised test meal 120 minutes after the test preload food. Which is the same test meal on each occasion.
2. Expected satiety before ingestion of the preload food measured using a 100 mm Visual Analogue Scale (VAS) 15 minutes before the preload, and 15 minutes after the preload
3. Food preferences and reward measured using the Leeds Food Preference Questionnaire (LFPQ) 15 minutes before the preload, and 15 minutes after the preload
Overall study start date01/04/2022
Overall study end date01/06/2025

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexBoth
Target number of participants444
Participant inclusion criteria1. Age >18 years
2. BMI >18.5 kg/m2
3. Able and willing to eat the study foods
4. Able and willing to attend the university at the required intervals
Participant exclusion criteria1. Report having had weight loss surgery
2. Report having a medical condition or taking medication that affects appetite/body weight (will be verified with a medication list within the ACEB group)
3. Smokers, or those who have given up within the last 6 months
4. Report having a history of or currently affected by an eating disorder
5. Report an allergy to any of the preload foods
6. Have insufficient English language skills to complete study questionnaires
Recruitment start date01/06/2023
Recruitment end date01/06/2025

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Human Appetite Research Unit
School of Psychology
Faculty of Medicine and Health
University of Leeds
Leeds
LS2 9JT
United Kingdom

Sponsor information

University of Leeds
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

Phone +44 (0)113 243 1751
Email J.Halford@leeds.ac.uk
Website https://www.leeds.ac.uk/
ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

Industry

Slimming World UK

No information available

Results and Publications

Intention to publish date02/02/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe anonymized data sets generated and analysed during the current study will be available upon request from Professor James Stubbs, r.j.stubbs@leeds.ac.uk.

Anonymised data that has any personally identifiable information removed will be available 3 years after study completion. Data will be available on request from the study contacts.

Editorial Notes

16/02/2024: Study's existence confirmed by the University of Leeds, School of Psychology Ethics Committee.