SucroMet Nutritional Intervention Trial

NCT07656298 | Recruiting

• 1 other identifier: SucroMet
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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 washout period. This design allows evaluation of the effects of sweetener type, dose, and mode of consumption. The primary outcomes are changes in glucose regulation, including fasting plasma glucose and insulin resistance assessed by HOMA-IR. Secondary outcomes include changes in body composition, anthropometric measurements, blood pressure, routine biochemical parameters, gut microbiota composition, DNA methylation patterns in peripheral blood cells, and biomarkers related to inflammation, oxidative stress, and metabolomic profiles measured in blood and urine. Participants will attend scheduled study visits for anthropometric assessments, dietary evaluations, and biological sample collection. Blood, urine, and stool samples will be obtained at baseline and after each intervention phase. The study aims to address the following questions:

1. 1.Do metabolic responses to sucrose and sucralose, including changes in insulin resistance (HOMA-IR) and fasting plasma glucose, differ according to participants' body mass index (BMI)?
2. 2.Do low and high doses of sucrose and sucralose differentially affect glucose regulation, body composition, and metabolic health?
3. 3.Does the mode of intake (solid versus liquid) influence changes in gut microbiota composition?
4. 4.Are changes in DNA methylation patterns in peripheral blood cells associated with the consumption of sucrose and sucralose at different doses and in different forms?
5. 5.Do different doses of sucrose and sucralose influence biomarkers related to inflammation, oxidative stress, and metabolomic profiles?

Conditions

Overweight , Obesity; Glucose Metabolism

Keywords

Sucrose; Sucralose; Sweeteners; Body Composition; Glucose Metabolism; Gut Microbiota; DNA Methylation; Inflammation; Oxidative Stress Biomarkers; Nutritional Intervention

Outcome Measures

Primary Outcomes (1)

• Change in HOMA-IR Index

  Insulin resistance will be assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Results will be reported as HOMA-IR values.

  Baseline (before intervention) and End of each 12-week intervention phase

Secondary Outcomes (7)

• Glycemic biomarker

  Baseline and End of each 12-week intervention phase

• Change in Fat Mass

  Baseline and End of each 12-week intervention phase

• Change in Systolic Blood Pressure

  Baseline and End of each 12-week intervention phase

• Change in Triglycerides

  Baseline and End of each 12-week intervention phase

• Change in Relative Abundance of Gut Microbiota

  Baseline and End of each 12-week intervention phase

Study Arms (4)

Sucrose - Low Dose

EXPERIMENTAL

Participants assigned to this arm will consume sucrose at a low dose equivalent to five percent of their individual estimated energy requirement. The sucrose will be incorporated into foods or beverages that are part of the habitual diet, while total daily calorie intake is maintained. Participants will complete two intervention phases, including solid and liquid intake forms, according to the crossover design.

Behavioral: Sucralose - Low Dose

Sucrose - High Dose

EXPERIMENTAL

Participants assigned to this arm will consume sucrose at a high dose equivalent to ten percent of their individual estimated energy requirement. The sucrose will be incorporated into foods or beverages that are part of the habitual diet, while total daily calorie intake is maintained. Participants will complete two intervention phases, including solid and liquid intake forms, according to the crossover design.

Behavioral: Sucrose - High Dose

Sucralose - Low Dose

EXPERIMENTAL

Participants assigned to this arm will consume a low dose of sucralose (approximately 33.35 mg/day), administered as five sucralose tablets per day and distributed across regular meals. The sucralose will be incorporated into foods or beverages consumed as part of the habitual diet while maintaining stable total daily energy intake. Participants will complete both solid and liquid intake intervention phases according to the crossover design.

Behavioral: Sucrose- Low dose

Sucralose - High Dose

EXPERIMENTAL

Participants assigned to this arm will consume a high dose of sucralose (approximately 66.7 mg/day), administered as ten sucralose tablets per day and distributed across regular meals. The sucralose will be incorporated into foods or beverages consumed as part of the habitual diet while maintaining stable total daily energy intake. Participants will complete both solid and liquid intake intervention phases according to the crossover design.

Behavioral: Sucralose - High Dose

Interventions

Sucrose- Low dose BEHAVIORAL

Sucrose administered at a dose equivalent to 5% of the participant's estimated daily energy requirement. The required amount is individually calculated and provided in pre-weighed sachets for daily consumption. Participants consume the assigned dose in foods or beverages during both intervention periods according to the crossover schedule.

Sucralose - Low Dose

Sucrose - High Dose BEHAVIORAL

Sucrose administered at a dose equivalent to 10% of the participant's estimated daily energy requirement. The required amount is individually calculated and provided in pre-weighed sachets for daily consumption. Participants consume the assigned dose in foods or beverages during both intervention periods according to the crossover schedule.

Sucrose - High Dose

Sucralose - Low Dose BEHAVIORAL

Sucralose tablets administered at a total dose of approximately 33.35 mg/day (5 tablets/day). Tablets are consumed daily and distributed across meals. Participants receive the assigned dose throughout both intervention periods and consume the sweetener in both solid and liquid forms according to the study crossover schedule.

Sucrose - Low Dose

Sucralose - High Dose BEHAVIORAL

Sucralose tablets administered at a total dose of approximately 66.7 mg/day (10 tablets/day). Tablets are consumed daily and distributed across meals. Participants receive the assigned dose throughout both intervention periods and consume the sweetener in both solid and liquid forms according to the study crossover schedule.

Sucralose - High Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Medical history and clinical evaluation;
• Absence of uncontrolled chronic diseases, such as diabetes, metabolic syndrome, severe hypertension, or advanced liver or renal disease; and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Junta de Andalucia: collaborator

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, 29103, Spain

RECRUITING

Related Links

• Public website providing general information related to the SUCROMET project, including background on the study topic and relevant updates on project progress.
• Public social media account used to share general and educational information related to the SUCROMET project and its scientific topic.

MeSH Terms

Conditions

Overweight; Obesity; Inflammation

Interventions

Sucrose; trichlorosucrose

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Libia Alejandra García Flores, PhD

  Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

  PRINCIPAL INVESTIGATOR

• José Manuel García Almeida, MD, PhD.

  Andaluz Health Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Libia Alejandra Garcìa Flores, PhD.

CONTACT

(+34) 951 440 260; libia.garcia@ibima.eu

José Manuel García Almeida, MD, PhD.

CONTACT

(+34) 951032244; jgarciaalmeida@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although the study is conducted as an open-label nutritional intervention, all study data will be coded prior to analysis. Investigators performing the statistical analyses will work with anonymized datasets and will not have access to information identifying participants or intervention groups. Group allocation codes will be disclosed only after completion of the primary analyses.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized nutritional intervention with a crossover component designed to evaluate the effects of sweetener type, dose, and mode of consumption. Participants are randomized to one of four intervention groups: low-dose sucrose, high-dose sucrose, low-dose sucralose, or high-dose sucralose, and remain on the same sweetener and dose throughout the study. Participants are recruited across normal-weight, overweight, and obesity BMI categories.Following a 4-week run-in period, participants are randomized to begin with either solid or liquid intake. After completing the first 12-week intervention period, participants undergo a 2-week washout and then cross over to the alternate intake form for a second 12-week intervention period. The crossover applies only to the mode of consumption (solid versus liquid), while sweetener type and dose remain unchanged.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

ES (1)