NCT04226911: SWEET

Sweeteners and Sweetness Enhancers: Prolonged Effects on Health, Obesity and Safety

Completed NA Last updated 1 November 2022

What this trial tests

NA trial testing S&SEs in Obesity in 379 participants. Completed in 6 October 2022.

Timeline

30 January 2020

Primary endpoint
6 October 2022

6 October 2022

Quick facts

Lead sponsor	Anne Birgitte Raben
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	379
Start date	30 January 2020
Primary completion	6 October 2022
Estimated completion	6 October 2022
Sites	4 locations across Denmark, Netherlands, Greece, Spain

Drugs / interventions tested

• S&SEs
• Sugar

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Anne Birgitte Raben

Who can join

Adults 6 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this randomised controlled trial (RCT) is to investigate if prolonged consumption of sweetener and sweetness enhancers (S\&SEs) within a healthy diet approach will improve weight loss maintenance and obesity related risk factors, and affect safety markers, compared to sugar.

We hypothesize, that:

* Prolonged use of S\&SEs in beverages and food matrices will result in improved body weight control because S\&SEs will increase palatability of the diet and thereby increase compliance to the recommendations for a healthy diet.
* There will be no safety concerns using S\&SEs in the long term.

Overweight/obese adults and families where at least one adult (both gender) and one child (both gender) are overweight/obese will be recruited. The majority of measurements will only be conducted in the adult population and some measurement will only be done in sub-groups. The intervention will be performed in four countries: Denmark, Greece, Spain and the Netherlands.

The goal is approximately 370 participants - 330 adults (18-65 years of age) and 40 children (6-12 years of age) - will be recruited for the study. All adult participants are first treated by a low energy diet (LED) for 2 months with the aim to reduce body weight (minimum 5% weight loss (WL)), whereas children are treated separately with a conventional weight maintenance (WM) diet, without a specific aim for absolute WL.

The participants - both adults and families - are randomized into two different diet interventions for 10 months with or without inclusion of S\&SEs products (foods and drinks). For adults, this period aims at preventing weight re-gain and for children maintaining body mass index (BMI)-for-age. The participants will receive food exchange lists and will be guided by dieticians. The randomization will be stratified by age, sex and BMI. Adults (not participating with children) belonging to the same household and all members of a family will be assigned the same intervention - the randomization will here solely be based on the oldest adult in the family/household.

The adult participants are weighed at months 0, 0.5 and 1, and if needed at month 1.5. They are supervised during the WL period at months 0 and 1, and if needed at months 0.5 and 1.5, and throughout the WM period at months 2, 4, 6, 9 and 12. Children will follow a similar, but less strict time schedule (their participation is preferred but not required for all dietician meetings).

The main assessment points are the clinical investigation days (CIDs) at month 0 (baseline, start of the WL period), 2 (end of the WL period/start of randomized intervention), 6 (6 months from baseline) and 12 (1 year from baseline).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of sweeteners and sweetness enhancers on weight management and gut microbiota composition in individuals with overweight or obesity: the SWEET study.
   Pang MD, Kjølbæk L, Bastings JJAJ, Andersen SSH, et al · · 2025 · cited 8× · PMID 41057614 · DOI 10.1038/s42255-025-01381-z
2. Distinct gut microbiota and metabolome features of tissue-specific insulin resistance in overweight and obesity.
   Jardon KM, Umanets A, Gijbels A, Trouwborst I, et al · · 2025 · cited 7× · PMID 40336254 · DOI 10.1080/19490976.2025.2501185
3. Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project.
   Kjølbæk L, Manios Y, Blaak EE, Martínez JA, et al · · 2022 · cited 4× · PMID 36223962 · DOI 10.1136/bmjopen-2022-061075
4. ZoomForward2022: European Congress on Obesity.
   · 2022 · cited 3× · PMID 35500564 · DOI 10.1159/000524469
5. Long-term effect of sweeteners and sweetness enhancers on gene expression markers of adipose tissue function, adipocyte morphology, and metabolic health: a SWEET substudy.
   Pang MD, Bastings JJAJ, Jocken JWE, Harrold JA, et al · · 2026 · PMID 42230988 · DOI 10.1038/s41366-026-02117-z
6. Acute and Prolonged Effects of Sweeteners and Sweetness Enhancers on Postprandial Appetite Sensations, Palatability, and Ad Libitum Energy Intake in Humans: A SWEET Sub-Study.
   Andersen SSH, Kjølbæk L, Halford JCG, Harrold JA, et al · · 2026 · PMID 41901122 · DOI 10.3390/nu18060948