Personalised advice to aid weight loss
| ISRCTN | ISRCTN51509551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51509551 |
| IRAS number | 283149 |
| Secondary identifying numbers | IRAS 283149 |
- Submission date
- 16/06/2021
- Registration date
- 16/06/2021
- Last edited
- 17/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Being overweight is very common. It is known to increase a person’s chance of developing several health conditions. These include heart disease, type 2 diabetes, fatty liver disease, and some cancers. Being overweight results from the interactions of different factors, including a person’s genes, their metabolism, their behaviour and their environment. The latter factors include people’s eating habits and how much exercise they do. However, both gaining and losing weight are complex because it is now known that the different factors interact (for example a person’s genes and what they eat). This is why some people put on weight more easily than others. Therefore, to fully understand weight gain and weight loss, we need to know about more than just what people eat; we also need to know about their genes and physical activity amongst other things. Personalised nutrition (PN) is a new approach which aims to give individuals unique nutrition advice based on their own genetic, environmental and lifestyle factors. Personalisation of interventions may help people to change behaviour in order to improve health outcomes, including weight loss. We plan to compare general advice from a dietitian with more personalised advice to see if the effect on weight loss is different. The personalised advice will be based upon knowing about the participant's genes and different chemicals measured in their blood. The main aim of the study is to compare the effects of standard versus personalised dietary advice on waist circumference. We will also measure a number of other things to do with body weight and health.
Who can participate?
Men and women over the age of 18 years who wish to lose weight. To be enrolled a person will need to have a body mass index of between 25 and 40 and a waist circumference of at least 94 cm for men and at least 80 cm for women.
What does the study involve?
The study involves three clinic visits; the provision of blood, saliva, urine and faecal samples; the completion of questionnaires; dietetic consultations; dietary change; and using an app.
Participants will attend clinic visit1 (V1) in the fasted state (no food or drink apart from water from 9 pm the night before). At V1 informed written consent will be provided. Height, weight, waist and hip circumference as well as body composition will be measured. Participants will provide a saliva sample, a blood sample (20 ml) and a urine sample (20 ml). Participants will be given breakfast after the saliva and blood samples are collected. They will complete two questionnaires asking about their diet: a food frequency questionnaire and a 3-day food diary. This appointment will last 1.5-2 hours. Participants will be asked to provide a small faecal sample (collected at home) prior to their next visit.
Visit 2 (V2) will be about a month after V1. At this visit participants will complete a set of questionnaires related to diet and lifestyle, quality of life, food shopping habits and physical activity. At this visit participants will be informed which group they have been allocated to and they will have a consultation with the study dietitian. The dietitian will help participants download an app to their phone (or tablet) and show them how to use the app. Participants will be able to contact the dietitian if you need any help in using the app. This appointment will last about 1.5 hours.
Participants will then follow their dietary plan for 4 months. If they are allocated to the group also receiving behaviour change prompts, they will receive information on ways that they can change their food and lifestyle choices via the app. During this 4 month period, all participants will complete a daily food diary using the app. At the end of months 1, 2 and 3 all participants will have a telephone consultation with the dietitian.
Visit 3 (V3) will take place about 4 months after V2. Participants will bring a recent faecal sample to this visit and as for V1 they will attend in the fasted state (no food or drink apart from water from 9 pm the night before). Height, weight, waist and hip circumference as well as body composition will be measured. Participants will provide a blood sample (20 ml) and a urine sample (20 ml). Participants will be given breakfast after the saliva and blood samples are collected. They will complete all questionnaires previously used at V1 and V2. This appointment will last about 2 hours.
What are the possible benefits and risks of participating?
Participants may benefit from losing weight whilst taking part in this study. They may gain helpful insights on how to improve their diet and lifestyle.
As part of the study participants will provide blood samples at the start and end of the study.
There is a very small chance of infection and a chance of bleeding and bruising at the site of insertion of the needle for collecting the blood sample, but this will be minimised by using sterile techniques and trained members of staff.
Where is the study run from?
The study is run from The Faculty of Medicine at the University of Southampton (Southampton, UK). Participants will make visits to the NIHR Clinical Research Facility in Southampton General Hospital.
When is the study starting and how long is it expected to run for?
February 2021 to April 2022.
Who is funding the study?
The study is funded by the European Commission.
Who is the main contact?
Professor Philip Calder, pcc@soton.ac.uk
Contact information
Scientific
Faculty of Medicine
University of Southampton
IDs Building
MP887
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0002-6038-710X |
|---|---|
| Phone | +44 (0)2381205250 |
| P.C.Calder@soton.ac.uk |
Public
Faculty of Medicine
University of Southampton
IDs Building
MP887
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381205250 |
|---|---|
| pcc@soton.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | ISRCTN51509551_PIS_v5.0_25Jan2021.doc |
| Scientific title | Trial of personalised advice to aid weight loss |
| Study hypothesis | 1. Personalised dietary advice will have a greater effect than standard dietetic advice on waist circumference, body weight, body fat, body mass index, metabolic profile, inflammatory markers and other outcomes in people with overweight or obesity. 2. Personalised dietary advice supported by behaviour change prompts will have a greatest effect on these same outcomes. |
| Ethics approval(s) | Approved 16/02/2021, East Midlands - Leicester Central Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8388; leicestercentral.rec@hra.nhs.uk), ref: 20/EM/0297 |
| Condition | Weight management in those with overweight and obesity |
| Intervention | Participants will be randomly allocated to one of three groups; randomisation will be stratified by age and sex and will be performed using an on-line randomisation programme. The three groups are: 1. Control group who will receive standard dietetic advice based upon assessment of participant's diet. 2. Dietetic advice also informed by knowledge of participant's metabolic, inflammatory and genetic profile. 3. Dietetic advice also informed by knowledge of participant's metabolic, inflammatory and genetic profile and supported by behaviour change prompts. Duration of intervention will be four months. |
| Intervention type | Behavioural |
| Primary outcome measure | Waist circumference (cm) measured using a tape measure at study entry (visit 1) and exit (visit 3) |
| Secondary outcome measures | 1. Hip circumference (cm) measured using a tape measure at study entry (visit 1) and exit (visit 3) 2. Waist to hip ratio (unitless) calculated from waist and hip circumferences measured at study entry (visit 1) and exit (visit 3) 3. Weight (kg) measured using weighing scales at study entry (visit 1) and exit (visit 3) 4. Body mass index (kg/m²) calculated from weight and height measurements at study entry (visit 1) and exit (visit 3) 5. Body fat mass (kg and %) and body lean mass (kg and %) by bioelectric impedance at study entry (visit 1) and exit (visit 3) 6. Dietary (amounts of foods) and nutrient (energy in calories and macronutrients in g and as % energy) intake assessed by food frequency questionnaire at study entry (visit 1) and exit (visit 3) 7. Quality of life assessed by questionnaire including a visual analog score at study entry (visit 2) and exit (visit 3) 8. Physical activity assessed by questionnaire at study entry (visit 2) and exit (visit 3) 9. Attitude to food assessed by questionnaire at study entry (visit 2) and exit (visit 3) 10. Serum glucose (mmol/l) and insulin (mU/l) concentrations at study entry (visit 1) and exit (visit 3) 11. HOMA-IR calculated using serum glucose and insulin concentrations at study entry (visit 1) and exit (visit 3) 12. Serum lipid (total, LDL and HDL cholesterol, triglycerides; all mmol/l) concentrations at study entry (visit 1) and exit (visit 3) 13. Serum adipokine (leptin, adiponectin; both ng/ml) concentrations and leptin/adiponectin ratio (unitless) at study entry (visit 1) and exit (visit 3) 14. Serum C-reactive protein (mg/l) concentration at study entry (visit 1) and exit (visit 3) 15. Plasma inflammatory biomarker (IL-6, MCP-1, IL-10, sICAM-1, sCD14, oxidized LDL; all ng/ml) concentrations at study entry (visit 1) and exit (visit 3) 16. Serum liver health markers (ALT, GGT; both U/l) at study entry (visit 1) and exit (visit 3) 17. Serum renal health markers (uric acid (mg/dl), creatinine (umol/l) at study entry (visit 1) and exit (visit 3) 18. Blood pressure (mmHg) at study entry (visit 1) and exit (visit 3) 19. Faecal microbiota (numbers of organisms/g faeces) at study entry (visit 1) and exit (visit 3) |
| Overall study start date | 16/02/2021 |
| Overall study end date | 30/04/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| Participant inclusion criteria | 1. Aged >18 years 2. Body mass index 25 - 40 kg/m² 3. Waist circumference >94 cm (for men) or >80 cm (for women) 4. Possess a mobile phone or other device capable of hosting the app 5. Able to provide written informed consent. |
| Participant exclusion criteria | 1. Diagnosed with diabetes or having a serum glucose ≥125 mg/dL (6.9 mmol/l) (at V1 blood sampling), other metabolic and endocrine disorders 2. Presence of chronic disease (cardiovascular disease, kidney disease (or a serum creatinine ≥ 1.7 mg/dl (150 µmol/l) for men and ≥ 1.5 mg/dl (132 µmol/l) for women at V1 blood sampling), cancer, pulmonary diseases, coeliac disease, Crohn’s disease, etc.) 3. Body mass index >40 kg/m² 4. Being pregnant or planning to become pregnant within the study period 5. Use of prescribed medicine to control blood glucose, inflammation or dyslipidemia (or LDL-cholesterol ≥4.9 mmol/L (>190 mg/dL) and/or triglycerides ≥4.5 mmol/L (≥400 mg/dL) at V1 blood sampling) 6. Consumption of more than 14 drinks of alcoholic beverages per week 7. Current smoking 8. Use of dietary supplements 9. Blood donation in the previous 3 months 10. No access to the internet 11. Note: Subjects with hypertension and taking antihypertensive drugs (metabolically neutral) will be not excluded and allowed to continue their prescribed dosage |
| Recruitment start date | 01/07/2021 |
| Recruitment end date | 30/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
University/education
University Road
Highfield
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0)2380595058 |
|---|---|
| rgoinfo@soton.ac.uk | |
| Website | http://www.southampton.ac.uk/ |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication(s) in peer-reviewed journals. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v5.0 | 25/01/2021 | 08/07/2021 | No | Yes |
| Protocol file | version V5 | 25/01/2021 | 08/07/2021 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
- ISRCTN51509551_PROTOCOL_V5_25Jan2021.docx
- Uploaded 08/07/2021
- ISRCTN51509551_PIS_v5.0_25Jan2021.doc
- Uploaded 08/07/2021
Editorial Notes
17/12/2024: The intention to publish date was changed from 31/12/2024 to 30/06/2025.
10/05/2024: The intention to publish date was changed from 30/06/2024 to 31/12/2024.
11/12/2023: The intention to publish date has been changed from 31/12/2023 to 30/06/2024.
10/07/2023: The intention to publish date was changed from 31/12/2022 to 31/12/2023.
08/07/2021: The participant information sheet has been uploaded. Uploaded protocol Version 5, 25 January 2021 (not peer reviewed).
16/06/2021: Trial's existence confirmed by East Midlands - Leicester Central Research Ethics Committee.
