Plain English Summary
Background and study aims
Changing the composition and structure of foods to have an effect on satiety (feeling full) and appetite by increasing feelings of fullness and reducing hunger. This has the potential to help people to lose weight, improve health and decrease the risk of long-term disease. The aim of this study is to find out whether a modified dairy product ("yoghurt/pudding") designed to enhance feelings of fullness and reduce energy intake would have beneficial effects on changes in body composition when consumed regularly during a 12-week moderate-intensity exercise programme.
Who can participate?
Healthy women aged between 18 and 55 years with a body mass index between 25 - 34.9 kg/m2.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given the modified (active) yoghurt/pudding and those in the second group are given the unmodifed (control) yoghurt/pudding. All participants are asked to eat the yoghurt/pudding they have been given four times a week for 12 weeks. During these 12 weeks, all participants take part in an exercise programme, which involves exercising five times a week for 12 weeks and burning 500 calories in each session (2500 per week). At the start of the study and after 12 weeks, participants in both groups are weighed and measured to see if there is any change to their weight or body composition. In addition, participants are also asked to wear a physical activity monitor and accelerometer and complete a physical activity diary for seven consecutive days at four time points throughout the study (at the start, during the first week and tenth week of the programme and after the end of the exercise programme). Finally, participants are required to have breakfast, lunch and dinner within the research unit on 4 occasions, two at the start of the study and two at the end, at which time blood samples are taken.
What are the possible benefits and risks of participating?
Undertaking regular moderate exercise has been associated with a reduction in resting heart rate, waist circumference, blood pressure, body fat and an increase in fitness. All these factors have been strongly associated with a reduced risk of many health problems including; strokes, heart conditions, some cancers, obesity, diabetes and many others. There is therefore a possibility that participants could benefit in this way. There are risks associated with exercising, which include, fainting, dizziness, muscle cramps and pulls. These risks are greatly reduced when the correct precautions are taken and the exercise is undertaken in a controlled and supervised environment. There is also a very small risk of exercise inducing a heart attack; again this is rare and especially rare when there is no pre-existing heart condition. There are also risks with eating food, which include food allergies and food contamination. To minimise the risk of these anyone who has a nut allergy or is allergic to any of the foodsbeing used will not be able to take part. All staff that will prepare food for participants will be required to pass a food hygiene and safety course. Staff will adhere to food safety regulations at all times. The final risks of taking part are those associated with blood samples being taken. The risks include; fainting, bruising and irritation. All researchers taking blood samples will be fully trained, and qualified first aiders.
Where is the study run from?
School of Psychology, University of Leeds (UK)
When is study starting and how long is it expected to run for?
June 2015 and June 2016
Who is funding the study?
European Union Framework 7 (Belgium)
Who is the main contact?
Dr Michelle Dalton
m.dalton@leeds.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Michelle Dalton
ORCID ID
http://orcid.org/0000-0003-0481-5429
Contact details
School of Psychology
University of Leeds
Lifton Place
Leeds
LS2 9JZ
United Kingdom
+44 113 343 5753
m.dalton@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LDS-2014-SMT
Study information
Scientific title
The medium-term effect of a modified texture and flavor release yoghurt/pudding with Satiagel® on satiation, satiety, body composition and weight loss following a 12-week exercise intervention in overweight/obese females
Acronym
SATIN-MT
Study hypothesis
The aim of this study is to:
1. Determine whether repeated consumption of the Active compared to the Control yoghurt/pudding in conjunction with regular exercise had beneficial effects on body weight and changes in body composition
2. Examine the effect of regular consumption of the Active compared to the Control yoghurt/pudding alongside an exercise intervention on measures of appetite control (i.e. satiation, satiety, peptide biomarkers and food hedonics)
Ethics approval
NRES Committee Yorkshire & the Humber, 02/04/2015, ref: 09/H1307/7
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
See additional files
Condition
Overweight and obesity
Intervention
Participants are randomised to one of two groups using the website https://www.random.org/lists/.
Active group: Participants receive the dairy product that contains the active ingredients.
Control group: Participants receive a calorie and taste matched dairy product that does not contain the active ingredients.
Participants in both groups consume their respective dairy products 4 times per week and expended 500 calories 5 times per week for 12 weeks. At the start of each week throughout the 12-week intervention, participants collect 4 servings of their respective dairy product to be consumed at home over the following 7-days. Participants are required to weigh the dairy product before and after consumption, and to fill in details regarding the date and time of consumption to ensure compliance. In total, participants consumed 48 dairy products across the 12-weeks. In addition to consuming the dairy products, at the start of the intervention participants are prescribed an exercise plan. This plan includes a target heart rate (70-80% of the participants’ maximum heart rate) and a number of minutes required for the participant to expend 500 calories. This is calculated using a cardiovascular fitness test to calculate VO2 max and was re-calibrated for each participant at Week 6. Participants complete their prescribed exercise 5 times per week (weekly expenditure of 2,500 calories) within the research unit.
Participants in both groups undergo weight and body measurements at baseline and 12 weeks. Blood samples are collected at baseline and on two probe days at the end of the intervention to assess appetite control, and participants have their physical activity monitored at baseline, 1, 10 and 12 weeks using a SenseWear armband mini.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
1. Body weight is measured using an electronic balance and recorded to the nearest 0.1kg at baseline, every week throughout the intervention and 12 weeks
2. Body composition (fat mass, fat free mass, and percentage body fat) is measured using air displacement plethysomography (BodPod, Concord, CA, USA) at baseline and 12 weeks
2.1. Standing height without shoes is measured to the nearest 0.5cm using a stadiometer at baseline and 12 weeks
2.2. Waist circumference (cm) is measured 1 cm above the top of the participants’ naval after expiration. The measurement is taken 3 times with an average of these measurements being used. Waist circumference is assessed at baseline and 12 weeks
2.3. Hip circumference is measured at the widest part of the participants' hip region. The measurement is taken 3 times with an average of these measurements being used. Hip circumference is assessed at baseline and 12 weeks
Secondary outcome measures
1. Appetite control (satiety, satiation, energy intake, peptide biomarkers and food hedonics) is assessed through recording of food intake and blood testing during two probe days (one to assess the effects of the Active dairy product and one to assess the effects of the Control dairy product) at the start of the intervention and two probe days at the end of the intervention
2. Free-living physical activity levels and sedentary behaviour are assessed using the SenseWear armband mini (SWA; Body Media) for 22 hours per day for 7-8 days at baseline, 1, 10 and 12 weeks
Overall trial start date
01/01/2015
Overall trial end date
29/06/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy female participants
2. Aged 18-55 years
3. BMI of 25 – 34.9 kg/m2
4. Not currently dieting to lose or gain weight
5. Not increased physical activity levels in the past 2-4 weeks
6. Regular breakfast eaters
7. Non-smokers
8. ≥4 liking of study foods (on 9-point Likert scale)
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
24
Participant exclusion criteria
1. Significant health problems
2. Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
3. Pregnant, planning to become pregnant or breastfeeding
4. History of anaphylaxis to food
5. Any known food allergies or food intolerance
5. Vegetarians
6. Smokers and those who have recently ceased smoking (within the last 3 months)
7. BMI <25 kg/m2 or >34.9 kg/m2
8. Volunteers self-reporting currently dieting or having lost or gained a significant amount of weight in the previous 6 months (>5%)
9. Volunteers who have significantly changed their physical activity patterns in the past 4 weeks (defined as changing them by >150 minutes per week)
10. Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
11. Participants (e.g. staff/students) who work in appetite or feeding related areas
12. Non-breakfast eaters
Recruitment start date
02/06/2015
Recruitment end date
22/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
School of Psychology
Faculty of Medicine and Health
University of Leeds
Leeds
LS2 9JZ
United Kingdom
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Study results will be published in a peer-reviewed journal and will be presented at scientific conferences.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from m.dalton@leeds.ac.uk
Intention to publish date
10/06/2017
Participant level data
Available on request
Results - basic reporting
Publication summary
Publication citations
Additional files
- ISRCTN78021668_PIS_v1_26Sep10.pdf Uploaded 28/09/2016