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

NCT02591134 | Completed

• 1 other identifier: ULKLABA01
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight

Keywords

weight loss; NNS; beverages; diet; appetite; satiety; weight control

Outcome Measures

Primary Outcomes (1)

• Initial change in weight

  weighing participants (kilograms)

  52 weeks

Secondary Outcomes (5)

• Changes in appetite/programme experience (all VAS)

  52 weeks

• Circulating biomarkers of health

  52 weeks

• Effects of beverages on food choice

  52 weeks

• Body composition change

  52 weeks

• Waist, hip and sagittal changes

  52 weeks

Study Arms (2)

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.

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.

Other: Control

Interventions

Non Nutritive Sweetened Beverages OTHER

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.

Non Nutritive Sweetened Beverages

Control OTHER

Water beverages provided in 330ml portions to be consumed twice per day over the duration of the trial

Control Water Beverages

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Professor Jason Halford: lead
• American Beverage Association: collaborator

Study Sites (1)

University of Liverpool

Liverpool, L69 7ZA, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 17634965 BACKGROUND

• 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.

  PMID: 7080884 BACKGROUND

• 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.

  PMID: 24862170 BACKGROUND

• Harrold 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.

  PMID: 37794246 DERIVED

• Masic 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.

  PMID: 27979755 DERIVED

MeSH Terms

Conditions

Body Weight; Weight Loss

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Jason Halford, Professor

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 29, 2015
• Study Start: July 1, 2016
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)