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Randomized Controlled Trial
. 2024 Jan;48(1):83-93.
doi: 10.1038/s41366-023-01393-3. Epub 2023 Oct 5.

Non-nutritive sweetened beverages versus water after a 52-week weight management programme: a randomised controlled trial

Joanne A Harrold  1 , Scott Hill  2 , Cristina Radu  2 , Paul Thomas  2 , Paula Thorp  2 , Charlotte A Hardman  2 , Paul Christiansen  2 , Jason C G Halford  2   3
Affiliations
Randomized Controlled Trial

Non-nutritive sweetened beverages versus water after a 52-week weight management programme: a randomised controlled trial

Joanne A Harrold et al. Int J Obes (Lond). 2024 Jan.

Abstract

Background/objective: Sugar-sweetened beverages are a substantial source of dietary sugar that can contribute to weight gain and the risk of type 2 diabetes. Dietary guidelines recommend non-nutritive sweetened (NNS) beverages to reduce sugar consumption, however, there is a need for long-term randomised controlled trials on their use. We aimed to compare the effects of NNS beverages and water on body weight during weight loss and maintenance in a behavioural weight management programme.

Methods: In this parallel-group, open-label, controlled equivalence trial, adults with a BMI of 27-35 kg/m2 who regularly consumed cold beverages were randomised 1:1 to water or NNS beverages. Participants underwent a group behavioural weight management programme comprising weekly (during the 12-week weight-loss phase) then monthly (during the 40-week weight-maintenance phase) meetings. The primary endpoint was weight change at week 52 (equivalence: two-sided P > 0.05). Secondary endpoints included changes in anthropometrics, cardiometabolic risk factors, appetite and activity levels.

Results: Of 493 participants randomised (water: n = 246; NNS beverages: n = 247), 24.1% were NNS-naïve. At week 52, water and NNS beverages were non-equivalent, with significantly greater weight loss in the NNS beverages group. Participants consuming water maintained a weight loss of 6.1 kg over 52 weeks versus 7.5 kg with NNS beverages (difference [90% CI]: 1.4 kg [-2.6, -0.2]; p < 0.05).

Conclusions: During a 52-week behavioural weight management programme, water and NNS beverages were non-equivalent, with weight loss maintained to a statistically greater extent with NNS beverages compared with water. However, this difference was not clinically significant.

Clinical trial registration: This trial is registered with ClinicalTrials.gov: NCT02591134.

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Conflict of interest statement

JAH reports funding (paid to the University of Liverpool) from the American Beverage Association for the present study. Outside of the submitted work, she reports a grant from the European Commission for the Horizon 2020 project SWEET. SH reports funding (paid to the University of Liverpool) from the American Beverage Association for the present study. CR reports funding (paid to the University of Liverpool) from the American Beverage Association for the present study. PThomas reports funding (paid to the University of Liverpool) from the American Beverage Association for the present study. PThorp reports funding (paid to the University of Liverpool) from the American Beverage Association for the present study. CAH reports funding (paid to the University of Liverpool) from the American Beverage Association for the present study. Outside of the submitted work, she reports honoraria from the International Sweeteners Association and International Food Information Council (paid to the University of Liverpool); grants from the European Commission for the Horizon 2020 project SWEET, the Biotechnology & Biological Sciences Research Council and the Natural Environment Research Council; personal fees for her role on the Food Standards Agency Advisory Committee on Social Sciences; and an unpaid role as a trustee of Feeding Liverpool. PC reports funding (paid to the University of Liverpool) from the American Beverage Association for the present study. Outside of the submitted work, he reports grants from the European Commission for the Horizon 2020 project SWEET, the National Institute for Health and Care Research, the Home Office UK and the Federal Bureau of Investigation; and personal fees from Kaplan. JCGH reports funding (paid to the University of Liverpool) from the American Beverage Association for the present study. Outside of the submitted work, he reports a grant from the European Commission for the Horizon 2020 project SWEET; consultancy fees from Boehringer Ingelheim, Dupont and Mars (all paid to the University of Leeds); honoraria from Novo Nordisk (paid to the University of Leeds); support for attending meetings from Novo Nordisk; financial support for participation in an advisory board for Dupont (paid to the University of Leeds); unpaid participation in an advisory board for the Sweet Tooth Project; and unpaid board membership of the European Coalition of People Living with Obesity. He is the President of the European Association for the Study of Obesity.

Figures

Fig. 1
Fig. 1. Flow of participants.
NNS non-nutritive sweetened. Some data have been reproduced with permission from Harrold JA, Hill S, Radu C, Thomas P, Thorp P, Hardman CA, et al. Effects of non-nutritive sweetened beverages versus water after a 12-week weight loss programme: a randomised controlled trial. Obesity (Silver Spring). 2023;31(8):1996–2008. © 2023 The Authors. aWeek 12 data were missing for 11 participants (n = 6 for water; n = 5 for NNS beverages) who remained in the trial. bWeek 52 data were missing for four participants (n = 2 for water; n = 2 for NNS beverages) who remained in the trial. These individuals were, therefore, not included in the analyses using the complete cases data set for the week-52 timepoint but were included in the analyses using the multiple imputation and last observation carried forward data sets. They may also contribute to analyses at future timepoints.
Fig. 2
Fig. 2. Time profile of weight change over 52 weeks in the complete cases data set.
a The change from baseline to week 52. b The change from week 12 to week 52. Primary analysis of the complete cases data set, which included all participants with data at baseline and week 52. The error bars are the standard error of the mean. The week-16 timepoint represents the first body-weight measurement during the weight-maintenance phase. NNS non-nutritive sweetened.
Fig. 3
Fig. 3. Violin plot showing the effect of trial beverage on selected variables at baseline and week 52 in the complete cases data set.
a Effect on body weight. b Effect on waist circumference. c Effect on hip circumference. Primary analysis of the complete cases data set, which included all participants with data at baseline and week 52. The shaded areas refer to the kernel density (the probability that a member of the population will have a given value), the boxes show the interquartile range, the horizontal lines in the centre of the boxes are the median values and the whiskers refer to 1.5× the interquartile range. NNS non-nutritive sweetened.
See this image and copyright information in PMC

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