Weight Clinical Trial
— SWITCHOfficial title:
SWITCH: EffectS of Non-nutritive sWeetened Beverages on appetITe During aCtive weigHt Loss
NCT number | NCT02591134 |
Other study ID # | ULKLABA01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | February 2024 |
Verified date | March 2024 |
Source | University of Liverpool |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 505 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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. - 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 Exclusion Criteria: - 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; - 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)) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Liverpool | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Professor Jason Halford | American Beverage Association |
United Kingdom,
Gormally 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. — View Citation
Peters 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Initial change in weight | weighing participants (kilograms) | 52 weeks | |
Secondary | 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 | 52 weeks | |
Secondary | Circulating biomarkers of health | Blood samples from all willing | 52 weeks | |
Secondary | 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) | 52 weeks | |
Secondary | Body composition change | Anthropometric measures (DXA in Subset 2) | 52 weeks | |
Secondary | Waist, hip and sagittal changes | Measurements in whole sample (all in centimetres) | 52 weeks |
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