WeightSWITCHNCT02591134
EffectS of Non-nutritive sWeetened Beverages on appetITe During aCtive weigHt Loss
A study testing Non Nutritive Sweetened Beverages in people with Weight, run by Professor Jason Halford at 1 site in United Kingdom.
Trial summary
The effects of non-nutritive sweetened (NNS) beverages on weight management and psychological indices of appetitive behaviour have not been assessed in both weight loss and maintained weight loss phases over the long term to determine whether NNS beverages may assist in efforts to lose weight and maintain weight loss… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight
- What is being tested?
- Non Nutritive Sweetened Beverages
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 505 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 27.0 and ≤ 35.0 kg/m2
- Healthy
- Age between 18 and 65 years (inclusive)
- Regular consumer of cold NNS or water beverages (>3 per week but < 2 litres per day)
- Acceptance of randomization to either a water or NNS beverage condition
- Willing to abstain from consuming NNS beverages (if randomized to the water condition) and SSBs for the duration of the trial.
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- Provided voluntary written informed consent
- Not planning on moving outside of the local area in the next 24 months
- Two individuals from the same household complying with the inclusion and exclusion criteria will be permitted to participate in the trial however, in such instances, the individuals will be randomized to the same group
Who cannot join
- Not willing to discontinue drinking NNS beverages for the duration of the trial should they be assigned to the water group and vice versa;
- Not willing to consume NNS beverages or water for the duration of the trial;
- Expressing a significant dislike of NNS beverages (at least moderately likeable on a 5 point likert scale);
- Excess consumer of chilled beverages or NNS beverages (more than 2 litres a day);
- A BMI below 27 or above 35 kg/m2;
- Below the age of 18 or above 65 years;
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- A first year University Student (to avoid the 'freshman 15' phenomenon of weight gain within the first year of attending University);
- Significant health problems (including a history of cardiovascular diseases);
- Gastro-intestinal problems or diabetes;
- Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study;
- Stated major psychiatric disorder (made clear by medicines specified);
- Current depression (made clear by medicines specified);
- Currently being treated for a psychological condition;
- Being pregnant, planning to become pregnant, breastfeeding or less than 6 months post-partum;
- Planning on moving away from the local area within the next two years;
- History of anaphylaxis to food; known food allergies or food intolerance;
- Dislike of > 25% of the study foods offered on the appetite probe day (Subset 1 only);
- Non breakfast eaters (subset 1 only);
- Smoking or having ceased smoking in the last six months;
- Currently dieting, having ceased a diet in less than 4 weeks, or having lost significant amounts of weight in the previous year;
- Engaging in regular intense exercise;
- Having significantly changed their physical activity patterns in the past 4 weeks or intending to change them during the study (other than to adhered to advice given in the behavioural intervention);
- Inability to adhere to the programme such as inability to increase activity level;
- Receiving systemic or local treatment likely to interfere with evaluation of the study parameters;
- Working in appetite or feeding-related disciplines;
- Being on specific food avoidance diets;
- Having had bariatric surgery;
- Having abnormal eating behaviour (restrained eaters measured by the Dutch Eating Behaviour Questionnaire - Restraint Scale [DEBQ-R] with a cut-off point of more than 4 (van Strien et al,1986); and binge eaters measured by the Binge Eating Scale with a cut-off point of 27 or over (Gormally et al, 1982))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SWITCH: EffectS of Non-nutritive sWeetened Beverages on appetITe During aCtive weigHt Loss
The effects of non-nutritive sweetened (NNS) beverages on weight management and psychological indices of appetitive behaviour have not been assessed in both weight loss and maintained weight loss phases over the long term to determine whether NNS beverages may assist in efforts to lose weight and maintain weight loss and how this affects appetite expression (satiety, food choice, craving, ease of dieting etc.). Thus the present research will determine the impact of NNS beverages as compared to water on weight loss and weight loss maintenance, satiation, satiety, cravings for sweet, exercise efforts and mood state across both a period of weight-loss as well as a weight-maintenance phase. To determine if the effects of NNS on appetite are beneficial or detrimental to successful weight management, the study will also systematically compare the effects of NNS beverages, water and caloric beverages (CBs) on appetite (hunger, satiety, liking and wanting) and energy intake (including food choice and caloric compensation) across the whole day during active weight management in a subset of participants.
Read the detailed description
The study will use a parallel randomized design with two arms; participants will either be randomized to a non-nutritive sweetener (NNS) beverage condition (active) or a water condition (control). A total of 432 overweight and obese participants (Body Mass Index; BMI range: 27-35 kg/m2) will be enrolled in the study. A 3-month weight loss diet phase will initially be completed, with participants receiving nutritional advice at weekly group sessions whilst additionally incorporating the active or control products into their diet (weeks 0-12). This programme is based on a model successfully used in an American sample (Peters et al., 2014) which will be adapted for a UK sample. This will be followed by a 9-month weight maintenance phase (weeks 13-49) in which participants will be advised to follow a general healthy diet in accordance with dietary guidelines (continuing to incorporate the active or control beverages) but will only attend monthly group sessions. This will be followed by a voluntary one year post assisted weight maintenance period in which participants will continue to consume the active or control beverages every day and will be asked to complete questionnaire measures, cognitive tasks, biomarkers of health (blood samples, if willing) and body composition data (weight, sagittal diameter and hip and waist circumference measures; DXA (for Subset 2)) at the end of this period. A subset of participants (Subset 1) will additionally undergo appetite probe days (n = 116), attending the Study Centre at 15 points throughout the trial (3 sessions at baseline, 3 sessions at the start of the weight loss programme, 3 sessions at the end of the weight loss programme, 3 sessions at the end of assisted weight maintenance and 3 sessions at the end of the one year post assisted weight maintenance period). A separate subset (Subset 2) will complete biological assessment measures (n =50) involving body composition (DXA) scans at 4 points throughout the trial (at baseline, end of weight loss, end of assisted weight maintenance, and at a year post assisted weight maintenance visit) and all participants will be asked to provide blood samples at these four points but will not be excluded from the trial should they not wish to.
Both groups will be asked to ensure that they consume at least two servings (330 ml) of their elected beverages dependent on condition (NNS vs. water). All beverages will be picked by participants (from a permitted range) and then delivered to them in bi-weekly batches using an online delivery-style system. Primary study visits for body weight, waist circumference, hip circumference, sagittal diameter, and blood pressure assessments will be carried out at various stages throughout the trial. Initial assessments will be at baseline (week -2), monthly over the weight loss period (weeks 4, 8 and 12), monthly over the assisted weight maintenance period (weeks 16, 20, 24, 28, 32, 36, 40, 44 and 48) and at a 1 year post assisted weight maintenance visit with Subset 2 additionally providing body composition (DXA) scans at baseline, at the end of the weight loss period, at the end of the assisted weight maintenance period and at a 1 year post assisted weight maintenance visit. During the weight loss phase, participants will meet in groups (10-12 participants) with a dietician-trained researcher every week (12 visits) followed by monthly meetings during the assisted weight maintenance phase (9 visits). Participants will additionally be asked to complete a series of questionnaires throughout the intervention period and complete a series of diet diaries (3-day diet diaries and food frequency questionnaires; FFQs) to assess compliance throughout the trial. Furthermore, empty product packaging (labels or bottles) will be collected as an additional compliance measure. The probe days to be completed by Subset 1 will involve participants attending the Study Centre at various times over an 8-hour day period for 3 meals (breakfast, lunch and dinner) and 1 drink (NNS, sugar sweetened beverage (SSB) or water) for a total of 15 sessions. Adverse events and concomitant medicine will be registered continuously throughout the study in relevant forms. For each participant, the total study duration is 100 weeks (not including recruitment and screening but including the voluntary post assisted weight maintenance phase) and includes a total of 39 visits (with additional visits for Subsets 1 and 2).
12-week weight loss programme. The 12-week Weight Loss Programme (WLP) will be based on the current successful UK-based dietician-designed nutritional knowledge and group work programme used within the Kissileff Laboratory, the content of which will be enhanced by a social cognition based programme currently used in Colorado. This employs a group based approach (10-12 participants) with frequent meetings (one per week) for a one hour session with a dietician trained researcher who will supervise the sessions and who will provide materials and 'home work' for the participants to complete before their next session. This programme will be tailored for the UK and specific behavioural components such as advice on self-monitoring, stimulus control, stress management, slow eating rate and related behaviours will be covered. An exercise component will also be included in which exercise activities are noted in a log and an additional online daily drinking log will also be included. The exercise log will be completed weekly and brought to each session as a means of monitoring. Weight will be measured at the start and end of this phase and weekly during the WLP as part of group sessions (at the end of the group session) and will be conducted privately with each participant in a separate room. Participants will also be asked to complete food frequency questionnaires (FFQs) once per month and online 3-day diet diaries before beginning the WLP and at the end of the WLP and will be given instructions on how to do so. In week 12 a further visit (independent from group sessions) will be scheduled individually with each participant to complete additional questionnaire and cognitive measures (Visit 13).
36-week assisted weight maintenance phase. Participants will be asked to attend one hour monthly group sessions with a dietician-trained researcher (10-12 participants per group) during the 36-week assisted weight maintenance phase running from week 13-48. These meetings will provide an opportunity for participants to discuss any concerns and to provide further reminders of nutritional advice. Body weight will be measured at the end of each group session and will be conducted privately with each participant in a separate room. Participants will also be asked to complete a series of questionnaires measuring appetite control and ease of dieting and measures of dietary compliance alongside providing the online daily beverage log and weekly paper exercise log. Participants will also be asked to complete FFQs monthly during this period. At the end of this phase further visits (independent from group sessions) will be scheduled to complete the final measures of appetite and food choice and to provide their final online 3-day diet diary.
Fasting blood samples will be analysed for glucose, insulin, lipids, triglycerides, high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol profiles and Hba1.
One year post assisted weight maintenance and visit After the final study visit post-maintenance (week 48), participants will continue to be provided either NNS or water beverages for a 12-month duration. They will be asked to return their empty beverage packaging monthly during this phase (weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96) and will complete retrospective appetite questionnaires alongside additional questionnaires upon returning their packaging. They will also complete daily online beverage logs online over the duration of the 12-month period and will complete a final online 3-day food diary which they present at Visit 39 (week 100). Participants in Subset 1 will additionally undergo a final set of probe days in weeks 98-99 (Visits 38a, 38b, and 38c). Subset 2 will also provide their final DXA scan at the one year post assisted weight maintenance period visit (Visit 39). At this final visit participants will be asked to provide a fasting blood sample as well as complete a range of computer tasks, questionnaires and food diaries. Their body weight will be measured and their waist, hip and sagittal diameter will be taken in a separate room along with their blood pressure
Subsets Subset 1 - Appetite Probe Days A voluntary subset of randomly selected participants (n=116) will be invited to participate in the appetite probe day sessions to assess changes in appetite response to caloric and non-caloric beverages (water, NNS and caloric beverages; CB). These probe days will be measured at baseline (Visits 2a, 2b \& 2c; weeks -2 to 0), at the start of the weight loss programme (Visits 3a, 3b and 3c; weeks 1 to 2), at the end of the weight loss period (Visits 13a, 13b and 13c; weeks 11 to 12) at the end of the assisted weight maintenance period (Visits 24a, 24b, 24c; weeks 47 to 48) and at the end of the 1 year post assisted weight maintenance period (Visits 38a, 38b, \& 38c). These sessions will be scheduled a minimum of 3 days after one another (minimum completion of 2 weeks) and must all be completed within a maximum of 3 weeks. At each point one probe day will examine the response to a caloric beverage (ie a sugar sweetened beverage; SSB) and then the second and third the response to NNS and water (the order of all three drinks will be counterbalanced across participants and probe days). These will be provided after breakfast and 1 hour before lunch (approximately 12pm). Compensation will then be tracked at an ad libitum test lunch and an evening meal. Participants will be blinded to the study condition (no information will be provided about the drinks during the probe days) however the sensory characteristics of the beverages may be evident. Cognitive and sensory cues cannot be matched but are important determinants of real world appetite responses.
The gold standard 8-hour design will be used. The appetite probe day will be conducted at the Kissileff Laboratory study centre and will involve participants attending the centre for a fixed breakfast (breakfast is calibrated based on weight bands which will be determined at the Screening session; prior to the end of WLP and prior to the end of the assisted weight maintenance phase to ensure accurate weight banding), the study beverage, ad libitum lunch and ad libitum dinner as well as a take-home snack pack for the remainder of the evening. Participants will complete appetite VAS pre- and post- each meal as well as completing these ratings at hourly intervals throughout the test day. They will be free to leave the Study Centre after consuming their meals and will be provided with water as well as a specified time to return for their next meal.
Subset 2 - DXA Scans In addition to trial participation, Subset 2 (n = 50) be asked to provide fasting full body DXA scan at dedicated visits 1d, 14a, 25a, and 39 (weeks 0, 12, 48 and the one year post assisted weight maintenance visit respectively). The DXA scan will be used to assess changes in body composition during the trial.
Participants will be reminded during the Screening session that they do not have to take part in the additional testing (Subsets 1 or 2) or provide blood samples to be eligible for enrolment in the trial.
- Conditions
- Weight
- Being tested
- Non Nutritive Sweetened Beverages, Control
- Keywords
- weight loss, NNS, beverages, diet, appetite, satiety, weight control
- Medical subject headings
- Body Weight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Nutritive Sweetened BeveragesOther
Non-nutritive sweeteners (NNS) beverages encompass a range of carbonated and still drinks with added artificial sweeteners. Participants will be provided with a list of permitted beverages and are expected to consume at least two portions (330ml) per day.
ControlOther
Water beverages provided in 330ml portions to be consumed twice per day over the duration of the trial
| Study group | Role | What they receive |
|---|---|---|
| Non Nutritive Sweetened Beverages | Experimental | Non-nutritive sweeteners (NNS) beverages will be provided to participants using a home delivery system and they are expected to consume at least two portions (330ml) per day. Receives: Other: Non Nutritive Sweetened Beverages |
| Control Water Beverages | Placebo comparator | Water beverages will be used as a comparator to NNS beverages during the trial. These beverages will encompass a range of water-based drinks that contain no NNS. Including water as a comparator is vital to understand whether NNS beverages are equally as effective as water during phases of weight loss and weight maintenance. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial change in weight
weighing participants (kilograms)
Measured: 52 weeks
Secondary outcomes (5)
Changes in appetite/programme experience (all VAS)
The experience of the weight loss programme and weight maintenance phases via associated questionnaires as well as assessments of appetite throughout the trial to detect changes in satiety (via associated questionnaires) - all one unit of measurement
Measured: 52 weeks
Circulating biomarkers of health
Blood samples from all willing
Measured: 52 weeks
Effects of beverages on food choice
Subset 1 will complete study days in which they are provided with caloric beverages, water or NNS beverages. Subsequent food choices with ad-libitum meals will then be assessed at various time points over the trial (calories consumed)
Measured: 52 weeks
Body composition change
Anthropometric measures (DXA in Subset 2)
Measured: 52 weeks
Waist, hip and sagittal changes
Measurements in whole sample (all in centimetres)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJul 2016
- Primary completionFeb 2024
- Study completionFeb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Jason Halford
- Sponsor type
- University, hospital or other
- Collaborators
- American Beverage Association
- Responsible party
- Sponsor-investigator, Professor Jason Halford, University of Liverpool
- Investigators
- Jason Halford, Professor, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591134
- Sponsor's protocol ID
- ULKLABA01
- Acronym
- SWITCH
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2015
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Ethically we cannot share individual participant data that may identify the individual. As stated in NHS ethics we do not plan on sharing this data with external parties to the PI, CI or University of Liverpool staff employed on the project
Publications
van Strien T, Oosterveld P. The children's DEBQ for assessment of restrained, emotional, and external eating in 7- to 12-year-old children. Int J Eat Disord. 2008 Jan;41(1):72-81. doi: 10.1002/eat.20424.
PubMed 17634965Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.
PubMed 7080884Peters JC, Wyatt HR, Foster GD, Pan Z, Wojtanowski AC, Vander Veur SS, Herring SJ, Brill C, Hill JO. The effects of water and non-nutritive sweetened beverages on weight loss during a 12-week weight loss treatment program. Obesity (Silver Spring). 2014 Jun;22(6):1415-21. doi: 10.1002/oby.20737.
PubMed 24862170Harrold JA, Hill S, Radu C, Thomas P, Thorp P, Hardman CA, Christiansen P, Halford JCG. Non-nutritive sweetened beverages versus water after a 52-week weight management programme: a randomised controlled trial. Int J Obes (Lond). 2024 Jan;48(1):83-93. doi: 10.1038/s41366-023-01393-3. Epub 2023 Oct 5.
PubMed 37794246Masic U, Harrold JA, Christiansen P, Cuthbertson DJ, Hardman CA, Robinson E, Halford JC. EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period. Contemp Clin Trials. 2017 Feb;53:80-88. doi: 10.1016/j.cct.2016.12.012. Epub 2016 Dec 12.
PubMed 27979755
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWITCH: EffectS of Non-nutritive sWeetened Beverages on appetITe During aCtive weigHt Loss
- ClinicalTrials.gov ID
- NCT02591134
- Acronym / sponsor ID
- SWITCH / ULKLABA01
- Conditions
- Weight
- Keywords
- weight loss, NNS, beverages, diet, appetite, satiety, weight control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Professor Jason HalfordUniversity, hospital or other
- Collaborators
- American Beverage Association
- Study start
- Jul 2016
- Primary completion
- Feb 2024 (actual)
- Study completion
- Feb 2024 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of non-nutritive sweetened (NNS) beverages on weight management and psychological indices of appetitive behaviour have not been assessed in both weight loss and maintained weight loss phases over the long term to determine whether NNS beverages may assist in efforts to lose weight and maintain weight loss and how this affects appetite expression (satiety, food choice, craving, ease of dieting etc.). Thus the present research will determine the impact of NNS beverages as compared to water on weight loss and weight loss maintenance, satiation, satiety, cravings for sweet, exercise efforts and mood state across both a period of weight-loss as well as a weight-maintenance phase. To determine if the effects of NNS on appetite are beneficial or detrimental to successful weight management, the study will also systematically compare the effects of NNS beverages, water and caloric beverages (CBs) on appetite (hunger, satiety, liking and wanting) and energy intake (including food choice and caloric compensation) across the whole day during active weight management in a subset of participants.
Detailed description
The study will use a parallel randomized design with two arms; participants will either be randomized to a non-nutritive sweetener (NNS) beverage condition (active) or a water condition (control). A total of 432 overweight and obese participants (Body Mass Index; BMI range: 27-35 kg/m2) will be enrolled in the study. A 3-month weight loss diet phase will initially be completed, with participants receiving nutritional advice at weekly group sessions whilst additionally incorporating the active or control products into their diet (weeks 0-12). This programme is based on a model successfully used in an American sample (Peters et al., 2014) which will be adapted for a UK sample. This will be followed by a 9-month weight maintenance phase (weeks 13-49) in which participants will be advised to follow a general healthy diet in accordance with dietary guidelines (continuing to incorporate the active or control beverages) but will only attend monthly group sessions. This will be followed by a voluntary one year post assisted weight maintenance period in which participants will continue to consume the active or control beverages every day and will be asked to complete questionnaire measures, cognitive tasks, biomarkers of health (blood samples, if willing) and body composition data (weight, sagittal diameter and hip and waist circumference measures; DXA (for Subset 2)) at the end of this period. A subset of participants (Subset 1) will additionally undergo appetite probe days (n = 116), attending the Study Centre at 15 points throughout the trial (3 sessions at baseline, 3 sessions at the start of the weight loss programme, 3 sessions at the end of the weight loss programme, 3 sessions at the end of assisted weight maintenance and 3 sessions at the end of the one year post assisted weight maintenance period). A separate subset (Subset 2) will complete biological assessment measures (n =50) involving body composition (DXA) scans at 4 points throughout the trial (at baseline, end of weight loss, end of assisted weight maintenance, and at a year post assisted weight maintenance visit) and all participants will be asked to provide blood samples at these four points but will not be excluded from the trial should they not wish to.
Both groups will be asked to ensure that they consume at least two servings (330 ml) of their elected beverages dependent on condition (NNS vs. water). All beverages will be picked by participants (from a permitted range) and then delivered to them in bi-weekly batches using an online delivery-style system. Primary study visits for body weight, waist circumference, hip circumference, sagittal diameter, and blood pressure assessments will be carried out at various stages throughout the trial. Initial assessments will be at baseline (week -2), monthly over the weight loss period (weeks 4, 8 and 12), monthly over the assisted weight maintenance period (weeks 16, 20, 24, 28, 32, 36, 40, 44 and 48) and at a 1 year post assisted weight maintenance visit with Subset 2 additionally providing body composition (DXA) scans at baseline, at the end of the weight loss period, at the end of the assisted weight maintenance period and at a 1 year post assisted weight maintenance visit. During the weight loss phase, participants will meet in groups (10-12 participants) with a dietician-trained researcher every week (12 visits) followed by monthly meetings during the assisted weight maintenance phase (9 visits). Participants will additionally be asked to complete a series of questionnaires throughout the intervention period and complete a series of diet diaries (3-day diet diaries and food frequency questionnaires; FFQs) to assess compliance throughout the trial. Furthermore, empty product packaging (labels or bottles) will be collected as an additional compliance measure. The probe days to be completed by Subset 1 will involve participants attending the Study Centre at various times over an 8-hour day period for 3 meals (breakfast, lunch and dinner) and 1 drink (NNS, sugar sweetened beverage (SSB) or water) for a total of 15 sessions. Adverse events and concomitant medicine will be registered continuously throughout the study in relevant forms. For each participant, the total study duration is 100 weeks (not including recruitment and screening but including the voluntary post assisted weight maintenance phase) and includes a total of 39 visits (with additional visits for Subsets 1 and 2).
12-week weight loss programme. The 12-week Weight Loss Programme (WLP) will be based on the current successful UK-based dietician-designed nutritional knowledge and group work programme used within the Kissileff Laboratory, the content of which will be enhanced by a social cognition based programme currently used in Colorado. This employs a group based approach (10-12 participants) with frequent meetings (one per week) for a one hour session with a dietician trained researcher who will supervise the sessions and who will provide materials and 'home work' for the participants to complete before their next session. This programme will be tailored for the UK and specific behavioural components such as advice on self-monitoring, stimulus control, stress management, slow eating rate and related behaviours will be covered. An exercise component will also be included in which exercise activities are noted in a log and an additional online daily drinking log will also be included. The exercise log will be completed weekly and brought to each session as a means of monitoring. Weight will be measured at the start and end of this phase and weekly during the WLP as part of group sessions (at the end of the group session) and will be conducted privately with each participant in a separate room. Participants will also be asked to complete food frequency questionnaires (FFQs) once per month and online 3-day diet diaries before beginning the WLP and at the end of the WLP and will be given instructions on how to do so. In week 12 a further visit (independent from group sessions) will be scheduled individually with each participant to complete additional questionnaire and cognitive measures (Visit 13).
36-week assisted weight maintenance phase. Participants will be asked to attend one hour monthly group sessions with a dietician-trained researcher (10-12 participants per group) during the 36-week assisted weight maintenance phase running from week 13-48. These meetings will provide an opportunity for participants to discuss any concerns and to provide further reminders of nutritional advice. Body weight will be measured at the end of each group session and will be conducted privately with each participant in a separate room. Participants will also be asked to complete a series of questionnaires measuring appetite control and ease of dieting and measures of dietary compliance alongside providing the online daily beverage log and weekly paper exercise log. Participants will also be asked to complete FFQs monthly during this period. At the end of this phase further visits (independent from group sessions) will be scheduled to complete the final measures of appetite and food choice and to provide their final online 3-day diet diary.
Fasting blood samples will be analysed for glucose, insulin, lipids, triglycerides, high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol profiles and Hba1.
One year post assisted weight maintenance and visit After the final study visit post-maintenance (week 48), participants will continue to be provided either NNS or water beverages for a 12-month duration. They will be asked to return their empty beverage packaging monthly during this phase (weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96) and will complete retrospective appetite questionnaires alongside additional questionnaires upon returning their packaging. They will also complete daily online beverage logs online over the duration of the 12-month period and will complete a final online 3-day food diary which they present at Visit 39 (week 100). Participants in Subset 1 will additionally undergo a final set of probe days in weeks 98-99 (Visits 38a, 38b, and 38c). Subset 2 will also provide their final DXA scan at the one year post assisted weight maintenance period visit (Visit 39). At this final visit participants will be asked to provide a fasting blood sample as well as complete a range of computer tasks, questionnaires and food diaries. Their body weight will be measured and their waist, hip and sagittal diameter will be taken in a separate room along with their blood pressure
Subsets Subset 1 - Appetite Probe Days A voluntary subset of randomly selected participants (n=116) will be invited to participate in the appetite probe day sessions to assess changes in appetite response to caloric and non-caloric beverages (water, NNS and caloric beverages; CB). These probe days will be measured at baseline (Visits 2a, 2b \& 2c; weeks -2 to 0), at the start of the weight loss programme (Visits 3a, 3b and 3c; weeks 1 to 2), at the end of the weight loss period (Visits 13a, 13b and 13c; weeks 11 to 12) at the end of the assisted weight maintenance period (Visits 24a, 24b, 24c; weeks 47 to 48) and at the end of the 1 year post assisted weight maintenance period (Visits 38a, 38b, \& 38c). These sessions will be scheduled a minimum of 3 days after one another (minimum completion of 2 weeks) and must all be completed within a maximum of 3 weeks. At each point one probe day will examine the response to a caloric beverage (ie a sugar sweetened beverage; SSB) and then the second and third the response to NNS and water (the order of all three drinks will be counterbalanced across participants and probe days). These will be provided after breakfast and 1 hour before lunch (approximately 12pm). Compensation will then be tracked at an ad libitum test lunch and an evening meal. Participants will be blinded to the study condition (no information will be provided about the drinks during the probe days) however the sensory characteristics of the beverages may be evident. Cognitive and sensory cues cannot be matched but are important determinants of real world appetite responses.
The gold standard 8-hour design will be used. The appetite probe day will be conducted at the Kissileff Laboratory study centre and will involve participants attending the centre for a fixed breakfast (breakfast is calibrated based on weight bands which will be determined at the Screening session; prior to the end of WLP and prior to the end of the assisted weight maintenance phase to ensure accurate weight banding), the study beverage, ad libitum lunch and ad libitum dinner as well as a take-home snack pack for the remainder of the evening. Participants will complete appetite VAS pre- and post- each meal as well as completing these ratings at hourly intervals throughout the test day. They will be free to leave the Study Centre after consuming their meals and will be provided with water as well as a specified time to return for their next meal.
Subset 2 - DXA Scans In addition to trial participation, Subset 2 (n = 50) be asked to provide fasting full body DXA scan at dedicated visits 1d, 14a, 25a, and 39 (weeks 0, 12, 48 and the one year post assisted weight maintenance visit respectively). The DXA scan will be used to assess changes in body composition during the trial.
Participants will be reminded during the Screening session that they do not have to take part in the additional testing (Subsets 1 or 2) or provide blood samples to be eligible for enrolment in the trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Nutritive Sweetened Beverages | Experimental | Other: Non Nutritive Sweetened BeveragesNon-nutritive sweeteners (NNS) beverages will be provided to participants using a home delivery system and they are expected to consume at least two portions (330ml) per day. |
| Control Water Beverages | Placebo comparator | Other: ControlWater beverages will be used as a comparator to NNS beverages during the trial. These beverages will encompass a range of water-based drinks that contain no NNS. Including water as a comparator is vital to understand whether NNS beverages are equally as effective as water during phases of weight loss and weight maintenance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- BMI ≥ 27.0 and ≤ 35.0 kg/m2
- Healthy
- Age between 18 and 65 years (inclusive)
- Regular consumer of cold NNS or water beverages (>3 per week but < 2 litres per day)
- Acceptance of randomization to either a water or NNS beverage condition
Key exclusion criteria (28 listed)
- Not willing to discontinue drinking NNS beverages for the duration of the trial should they be assigned to the water group and vice versa;
- Not willing to consume NNS beverages or water for the duration of the trial;
- Expressing a significant dislike of NNS beverages (at least moderately likeable on a 5 point likert scale);
- Excess consumer of chilled beverages or NNS beverages (more than 2 litres a day);
- A BMI below 27 or above 35 kg/m2;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Nutritive Sweetened BeveragesNon-nutritive sweeteners (NNS) beverages encompass a range of carbonated and still drinks with added artificial sweeteners. Participants will be provided with a list of permitted beverages and are expected to consume at least two portions (330ml) per day. | Other | Non Nutritive Sweetened Beverages |
| ControlWater beverages provided in 330ml portions to be consumed twice per day over the duration of the trial | Other | Control Water Beverages |
Primary outcome
Initial change in weight
Time frame: 52 weeks
weighing participants (kilograms)
5 secondary outcomes
Changes in appetite/programme experience (all VAS)
Time frame: 52 weeks
Circulating biomarkers of health
Time frame: 52 weeks
Effects of beverages on food choice
Time frame: 52 weeks
Body composition change
Time frame: 52 weeks
Waist, hip and sagittal changes
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 17634965van Strien T, Oosterveld P. The children's DEBQ for assessment of restrained, emotional, and external eating in 7- to 12-year-old children. Int J Eat Disord. 2008 Jan;41(1):72-81. doi: 10.1002/eat.20424.
- Background: PubMed 7080884Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.
- Background: PubMed 24862170Peters JC, Wyatt HR, Foster GD, Pan Z, Wojtanowski AC, Vander Veur SS, Herring SJ, Brill C, Hill JO. The effects of water and non-nutritive sweetened beverages on weight loss during a 12-week weight loss treatment program. Obesity (Silver Spring). 2014 Jun;22(6):1415-21. doi: 10.1002/oby.20737.
- Derived from this study: PubMed 37794246Harrold JA, Hill S, Radu C, Thomas P, Thorp P, Hardman CA, Christiansen P, Halford JCG. Non-nutritive sweetened beverages versus water after a 52-week weight management programme: a randomised controlled trial. Int J Obes (Lond). 2024 Jan;48(1):83-93. doi: 10.1038/s41366-023-01393-3. Epub 2023 Oct 5.
- Derived from this study: PubMed 27979755Masic U, Harrold JA, Christiansen P, Cuthbertson DJ, Hardman CA, Robinson E, Halford JC. EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period. Contemp Clin Trials. 2017 Feb;53:80-88. doi: 10.1016/j.cct.2016.12.012. Epub 2016 Dec 12.
- Individual participant dataSharing planned: No. Ethically we cannot share individual participant data that may identify the individual. As stated in NHS ethics we do not plan on sharing this data with external parties to the PI, CI or University of Liverpool staff employed on the project
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Halford, Professor principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Nutritive Sweetened Beverages in people with Weight, run by Professor Jason Halford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial change in weight (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591134, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.