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EffectS of Non-nutritive sWeetened Beverages on appetITe During aCtive weigHt Loss (SWITCH)

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ClinicalTrials.gov Identifier: NCT02591134
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
American Beverage Association
Information provided by (Responsible Party):
Professor Jason Halford, University of Liverpool

Brief 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 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.

Condition or disease Intervention/treatment Phase
Weight Other: Non Nutritive Sweetened Beverages Other: Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: SWITCH: EffectS of Non-nutritive sWeetened Beverages on appetITe During aCtive weigHt Loss
Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non Nutritive Sweetened Beverages
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.
Other: Non Nutritive Sweetened Beverages
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.

Placebo Comparator: Control Water Beverages
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.
Other: Control
Water beverages provided in 330ml portions to be consumed twice per day over the duration of the trial




Primary Outcome Measures :
  1. Initial change in weight [ Time Frame: 100 weeks ]
    weighing participants (kilograms)


Secondary Outcome Measures :
  1. Changes in appetite/programme experience (all VAS) [ Time Frame: 100 weeks ]
    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

  2. Circulating biomarkers of health [ Time Frame: 100 weeks ]
    Blood samples from all willing

  3. Effects of beverages on food choice [ Time Frame: 100 weeks ]
    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)

  4. Body composition change [ Time Frame: 100 weeks ]
    Anthropometric measures (DXA in Subset 2)

  5. Waist, hip and sagittal changes [ Time Frame: 100 weeks ]
    Measurements in whole sample (all in centimetres)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591134


Contacts
Contact: Jason Halford, Professor 0151 794 2952 J.C.G.Halford@liverpool.ac.uk
Contact: Joanne Harrold, PhD 0151 794 1136 harrold@liverpool.ac.uk

Locations
United Kingdom
University of Liverpool Recruiting
Liverpool, United Kingdom, L69 7ZA
Sponsors and Collaborators
Professor Jason Halford
American Beverage Association
Investigators
Principal Investigator: Jason Halford, Professor University of Liverpool

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Jason Halford, Professor, University of Liverpool
ClinicalTrials.gov Identifier: NCT02591134     History of Changes
Other Study ID Numbers: ULKLABA01
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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

Keywords provided by Professor Jason Halford, University of Liverpool:
weight loss
NNS
beverages
diet
appetite
satiety
weight control

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes