Condition: Overweight , Obesity · Glucose Metabolism · Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
SucroMet is designed to evaluate how adding two commonly used sweeteners-sucrose (table sugar) and sucralose (a low-calorie sweetener)-at low and high doses may influence glucose regulation, including insulin resistance and fasting plasma glucose, in adults aged 18 to 65 years with normal weight, overweight, or obesity. The low-dose intervention consists of 5% of the Estimated Energy Requirement (EER) from sucrose or 5 sucralose tablets per day (approximately 33.35 mg/day of sucralose). The high-dose intervention consists of 10% of EER from sucrose or 10 sucralose tablets per day (approximately 66.7 mg/day of sucralose). These doses maintain the planned 1:2 exposure ratio between the low- and high-dose intervention groups. Before the intervention begins, participants' habitual dietary intake is assessed and, when necessary, minor dietary adjustments are made to support a stable overall eating pattern while maintaining energy intake. Participants then complete a four-week run-in period during which these recommendations are followed, and dietary records are used to verify dietary stability before the intervention starts. Participants will consume the assigned sweetener incorporated into foods or beverages that they already consume as part of their habitual diet, without substantial changes to their usual eating patterns. The intervention includes two consecutive 12-week phases, one involving solid food intake and the other involving liquid intake, separated by a two-week wa…
This description comes directly from the study's public registry record.
Libia Alejandra Garcìa Flores, PhD. · (+34) 951 440 260 · libia.garcia@ibima.eu
José Manuel García Almeida, MD, PhD. · (+34) 951032244 · jgarciaalmeida@uma.es
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| Hospital Universitario Virgen de la Victoria | Málaga, Malaga, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07656298