Abstract
Sweeteners and sweetness enhancers (S&SEs) are ingredients used in foods and beverages to reduce sugar while providing the sweetness of sugar with little to no calories. Although S&SEs have global regulatory approval and acceptance, questions remain regarding their overall safety and efficacy. Information on the effects of S&SEs in regard to health and efficacy can be found in randomised controlled trials (RCTs) that exist in peer-reviewed literature. With the large number of RCT publications on various S&SEs, a need exists to organise and collect each of the published studies in a useful database. Currently, a database containing human clinical information on S&SEs does not exist and so The SWEET project has created a publicly available and comprehensive Health Impact Database that includes available human clinical information on sweeteners. This paper describes the process and development of a database that collects comprehensive information on published human clinical studies evaluating S&SEs between the years January 2000 and September 2024. Ovid Medline was used to search for RCT publications from the year 2000 to 2024. The search produced 1538 publications, of which 257 complied with the predetermined eligibility criteria. There was a large variability in the number of studies that fit the inclusion criteria. For example, some S&SEs had numerous studies (i.e., sucralose, n = 63 eligible publications) and some S&SEs had no publications that fit the criteria (aspartame-acesulfame K salt and neohesperidine DC). The Health Impact Database is located at https://sweetproject.eu/database-spreadsheets/ and is contained in Microsoft Excel spreadsheets which are organised by health impact criteria. This database will be a useful tool for researchers as it provides comprehensive information on human clinical studies on S&SEs that can be leveraged as a general resource and for systematic reviews and meta-analyses.
Summary
This paper outlines the process and development of the SWEET Project’s Health Impact Database, the first publicly available and comprehensive resource collecting human randomized controlled trials (RCTs) that investigate the health effects of low- and no-calorie sweeteners (LNCS).
As stated in the paper, the primary aim of the project was to build a reference tool for RCTs evaluating sweeteners and sweetness enhancers (S&SEs), which could also support systematic reviews and meta-analyses.
The database includes 257 RCTs published between January 2000 and September 2024 that met predefined inclusion criteria.
A large variability was observed in the number of eligible studies per LNCS. For example, sucralose had 63 eligible publications, whereas others, such as neohesperidine DC, had none.
In terms of health outcomes, the most frequently studied were glucose homeostasis, energy intake, and body weight, while the least studied were oral health and gut microbiome.
The Health Impact Database is publicly available at https://sweetproject.eu/database-spreadsheets/.