SucroMet: Does table sugar or sucralose affect glucose control in adults of different weights?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SucroMet is a randomized controlled nutrition study that compares the metabolic effects of two sweeteners—sucrose and sucralose—across two dose levels (low and high) while keeping overall energy intake and eating patterns as stable as possible. The study also explores whether the form of delivery (solid versus liquid) and body weight category modify responses in glucose regulation and related pathways. Participants undergo a run-in period, followed by a four-week stabilization phase and then the randomized sweetener interventions. Outcomes include fasting glucose and insulin resistance, with ancillary analyses on gut microbiota, epigenetics, inflammation, and systemic metabolic profiles. The design aims to isolate the specific impact of sweetener exposure on metabolism by controlling diet and examining multiple biological pathways.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 to 65 years at the time of enrollment.
* Body Mass Index (BMI) between 18.5 and 39.9 kg/m².
* Men and women who report a preference for sweet taste and habitual consumption of sugar and/or sweeteners.
* Individuals in good general health, as determined by:

  1. Medical history and clinical evaluation;
  2. Absence of uncontrolled chronic diseases, such as diabetes, metabolic syndrome, severe hypertension, or advanced liver or renal disease; and
  3. Baseline biochemical parameters within normal reference ranges, including fasting plasma glucose \<100 mg/dL, HbA1c \<5.7%, normal liver and renal function (ALT/AST and creatinine within reference ranges), and blood pressure \<140/90 mmHg without pharmacological treatment.
* Less than 4 hours per week of moderate-to-vigorous physical activity.
* Not following special or restrictive diets (e.g., ketogenic, strict vegetarian, or vegan diets).
* Not taking medications known to affect metabolism, including, for example, antidiabetic drugs, systemic corticosteroids, weight-loss medications, or high-dose antioxidant supplements, except for stable use of hormonal contraceptives.
* Willingness to maintain habitual diet and physical activity throughout the study, with the only modification being the assigned sweetener intervention.
* Ability and willingness to comply with all study procedures and scheduled visits.
* Provision of written informed consent before participation.

Exclusion Criteria:

* Gastrointestinal disorders influencing digestion or nutrient absorption (e.g., inflammatory bowel disease, celiac disease, malabsorption syndromes).
* History of cancer not in remission.
* Uncontrolled thyroid disorders.
* History of bariatric surgery or extreme weight loss within the past 12 months.
* Pregnancy, breastfeeding, or planning pregnancy during the study period.
* Acute illness, major infection, hospitalization, or major surgery within the previous 6 months.
* Any condition that, in the investigators' judgment, could compromise participant safety, protocol adherence, or interpretation of the study results.

Where it's running

• Hospital Universitario Virgen de la Victoria
  Málaga, Malaga, Spain Recruiting

Study contacts

• Principal investigator: Libia Alejandra García Flores, PhD — Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
• Study coordinator: Libia Alejandra Garcìa Flores, PhD.
• Email: libia.garcia@ibima.eu
• Phone: (+34) 951 440 260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.