Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/05/2011
Date assigned
18/05/2011
Last edited
27/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 don’t 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 measures

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

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22030223

Publication citations

  1. 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.

Additional files

Editorial Notes