Plain English Summary
Background and study aims?
Worldwide, more and more people are putting on weight, and there is an urgent need to try and understand what leads to over-consumption so we can help provide better health advice and promote the development of new products that can help people control their weight. One intriguing finding is that when people drink a drink which has a high energy content, they dont feel full and eat less afterwards. In contrast, if they have the same energy as a bowl of soup, they are able to adjust the amount they eat later quite accurately. The aim of this study is to try and find out why this is.
Who can participate?
As this study is not aiming to help specific patient groups, potential participants are normal members of the public who are healthy. As the study does require people to eat foods and drinks, you should not take part if you are diabetic, are taking prescription medications, smoke more than 5 cigarettes a day or have a diagnosed eating problem.
What does the study involve?
If you took part, you would come to our test centre on 7 different days. Day 1 would be a screening and familiarization day, and the subsequent 6 days would be the test sessions. On each of these days you would be required to eat nothing and to drink only water from 11pm on the previous night, and would first come for a simple breakfast between 8am and 10am. You would then come back 3 hours later and would be asked to consume a test drink (in the form of a fruit-juice/yoghurt drink) and then 30 minutes later would be served a lunch of pasta followed by ice-cream.
What are the possible benefits and risks of participating?
As the study involves eating foods and drinks made from regular ingredients, the only risks are to people who suffer from diabetes to who have an allergy to any of the ingredients. We will screen all volunteers and if you have diabetes or food allergies you would not be allowed to participate.
Where is the study run from?
University of Sussex.
When does the study taking place?
The study took place between March 2010 and August 2010.
Who is funding the project?
The project is funded by the UK Biotechnology and Biological Sciences Research Council (BBSRC).
Who is the main contact?
Professor Martin Yeomans
martin@sussex.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Martin Yeomans
ORCID ID
Contact details
School of Psychology
Pevensey Building
University of Sussex
Falmer
Brighton
BN1 9QH
United Kingdom
+44 (0) 127 367 8617
martin@sussex.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MYDRINC2010.1
Study information
Scientific title
Acronym
SATED
Study hypothesis
Disguised energy consumed in a novel drink will be more efficient in generating satiety when the drink has sensory characteristics that generate satiety relevant expectations. [Satiety Augmentation Through Expectation Delivery (SATED)]
Ethics approval
University of Sussex Research Governance Committee on 22 January 2010 Ref: MY0110appro
Study design
Observational non randomised.
Primary study design
Observational
Secondary study design
Other
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Treatment of obesity and improved general nutrition.
Intervention
1. The six interventions are novel drinks formulated especially for the study, (low calorie, 78kcal, high calorie 279kcal)
2. All low energy (LE) drinks comprised of a combination of low-fat fromage frais and fruit juice with added flavourings and colours (78kcal)
3. The additional 201kcal in the high energy (HE) versions was achieved by adding maltodextrin (Cargill: 35g) and whey protein isolate (Myprotein, UK: 25g)
4. These drinks constituted the two low sensory versions
5. Sensory quality was adjusted by addition of a non-nutritive thickening agent (tara gum) and satiety-relevant flavours (vanilla and caramel) at two levels to generate medium and high sensory versions of both LE and HE drinks
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Intake (kcal) at a test lunch consumed 30 minutes after consumption of each test drink
2. The rated experience of appetite before, during and after consumption of each test drink and test meal measured using Visual Analogue Scales
3. Measures will be for hunger and fullness
Secondary outcome measures
1. Evaluations using Visual Analogue Scales of the perceived sensory characteristics of each drink (pleasant, filling, sweet, creamy)
2. Specific awareness of drink energy content obtained through a structured debriefing after the final test session
Overall trial start date
10/02/2010
Overall trial end date
25/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy adults aged 18-55
2. BMI in the range 18-29.9
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36 volunteers, 18 men and 18 women
Participant exclusion criteria
1. Diagnosed diabetes
2. Current prescription medication other than oral contraceptives
3. Current or previous diagnosis of any eating disorder
4. Smoking more than 5 cigarettes per day
5. Restrained eating, defined as a score of 8 or more on the Three Factor Eating Questionnaire restraint scale (Stunkard and Messick, 1985)
6. Allergy or aversion to any of the following:
Recruitment start date
10/02/2010
Recruitment end date
25/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Psychology
Brighton
BN1 9QH
United Kingdom
Sponsor information
Organisation
University of Sussex (UK)
Sponsor details
Sussex House
Brighton
Brighton
BN1 9RH
United Kingdom
c.m.mcleod@sussex.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
UK Biotechnology and Biological Sciences Research Council (BBSRC) Diet and Health Research Industry Club (DRINC) grant number BB/H004645/1
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22030223
Publication citations
-
Results
Yeomans MR, Chambers L, Satiety-relevant sensory qualities enhance the satiating effects of mixed carbohydrate-protein preloads., Am. J. Clin. Nutr., 2011, 94, 6, 1410-1417, doi: 10.3945/ajcn.111.011650.