The medium-term effect of a modified yoghurt/pudding on appetite and weight loss following a 12-week exercise intervention in females who are overweight/obese
| ISRCTN | ISRCTN78021668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78021668 |
| Secondary identifying numbers | LDS-2014-SMT |
- Submission date
- 16/09/2016
- Registration date
- 27/09/2016
- Last edited
- 23/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
School of Psychology
University of Leeds
Lifton Place
Leeds
LS2 9JZ
United Kingdom
 ORCID ID |
0000-0003-0481-5429 |
|---|---|
| Phone | +44 113 343 5753 |
| m.dalton@leeds.ac.uk |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | ISRCTN78021668_PIS_v1_26Sep10.pdf |
| 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 |
| Study acronym | SATIN-MT |
| Study objectives | 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(s) | NRES Committee Yorkshire & the Humber, 02/04/2015, ref: 09/H1307/7 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2015 |
| Completion date | 29/06/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target number of participants | 24 |
| Total final enrolment | 24 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 02/06/2015 |
| Date of final enrolment | 22/02/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Faculty of Medicine and Health
University of Leeds
Leeds
LS2 9JZ
United Kingdom
Sponsor information
University/education
University of Leeds
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Results and Publications
| Intention to publish date | 10/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1 | 26/09/2010 | 28/09/2016 | No | Yes |
| Results article | results | 01/02/2019 | 23/03/2020 | Yes | No |
Additional files
- ISRCTN78021668_PIS_v1_26Sep10.pdf
- Uploaded 28/09/2016
Editorial Notes
23/03/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
28/09/2016: Participant information sheet uploaded.
