SucroMet Nutritional Intervention Trial

June 15, 2026 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

SucroMet' Nutritional Intervention: Study of the Metabolic Impact of Sucrose (Natural Sugar) and Sucralose (Artificial Sweetener) Intake at Different Doses and Modes of Consumption in Adults With Normal Weight, Overweight, and Obesity

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. 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. Do low and high doses of sucrose and sucralose differentially affect glucose regulation, body composition, and metabolic health?
  3. Does the mode of intake (solid versus liquid) influence changes in gut microbiota composition?
  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. Do different doses of sucrose and sucralose influence biomarkers related to inflammation, oxidative stress, and metabolomic profiles?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

SucroMet is a randomized controlled nutritional intervention designed to investigate the metabolic effects of sucrose and sucralose consumption under conditions that closely reflect habitual dietary practices. The study aims to determine whether sweetener type, dose, and mode of consumption influence glucose regulation and related biological pathways in adults with normal weight, overweight, or obesity. The study evaluates the independent and combined effects of sweetener type, dose, and mode of consumption. By maintaining overall dietary habits and energy intake as stable as possible throughout the intervention, the design aims to isolate the specific contribution of sweetener exposure to observed metabolic changes.

A distinctive feature of the study is the comparison of sweeteners administered in both solid and liquid forms, allowing assessment of whether the food matrix modifies physiological responses. The study also examines whether responses differ according to adiposity status, enabling exploration of potential interactions between sweetener exposure and body mass index.

Beyond glucose regulation, the study investigates several biological pathways that may contribute to individual variability in response to sweetener intake, including gut microbiota composition, epigenetic regulation, inflammation, oxidative stress, and systemic metabolic profiles. The integration of clinical, biochemical, molecular, and metabolomic data is intended to provide a comprehensive characterization of the biological effects associated with long-term sweetener consumption.

The results are expected to improve understanding of the metabolic consequences of sucrose and sucralose intake and to contribute evidence relevant to future nutritional recommendations and public health strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Libia Alejandra Garcìa Flores, PhD.
  • Phone Number: (+34) 951 440 260
  • Email: libia.garcia@ibima.eu

Study Contact Backup

  • Name: José Manuel García Almeida, MD, PhD.
  • Phone Number: (+34) 951032244
  • Email: jgarciaalmeida@uma.es

Study Locations

  • Spain
    • Malaga
      • Málaga, Malaga, Spain, 29103
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sucrose - Low Dose
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
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.
Experimental: Sucrose - High Dose
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
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.
Experimental: Sucralose - Low Dose
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
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.
Experimental: Sucralose - High Dose
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HOMA-IR Index
Time Frame: Baseline (before intervention) and End of each 12-week intervention phase
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glycemic biomarker
Time Frame: Baseline and End of each 12-week intervention phase
Change in Hemoglobin A1c (%): Hemoglobin A1c measured as an indicator of long-term glycemic control.
Baseline and End of each 12-week intervention phase
Change in Fat Mass
Time Frame: Baseline and End of each 12-week intervention phase
Fat mass (kg) is assessed using bioelectrical impedance analysis (BIA).
Baseline and End of each 12-week intervention phase
Change in Systolic Blood Pressure
Time Frame: Baseline and End of each 12-week intervention phase
Systolic blood pressure is measured under standardized clinical conditions using validated devices.
Baseline and End of each 12-week intervention phase
Change in Triglycerides
Time Frame: Baseline and End of each 12-week intervention phase
Triglyceride levels (mg/dL) are measured using standard clinical laboratory methods.
Baseline and End of each 12-week intervention phase
Change in Relative Abundance of Gut Microbiota
Time Frame: Baseline and End of each 12-week intervention phase
Gut microbiota composition is assessed in stool samples using 16S rRNA gene sequencing by quantifying the relative abundance of bacterial taxa at different taxonomic levels.
Baseline and End of each 12-week intervention phase
Change in DNA Methylation in Peripheral Blood Mononuclear Cells
Time Frame: Baseline and End of each 12-week intervention phase
DNA methylation levels are assessed in peripheral blood mononuclear cells (PBMCs) by quantifying methylation at specific CpG sites using bisulfite-based epigenetic analysis techniques.
Baseline and End of each 12-week intervention phase
Change in Urinary Oxylipin Levels
Time Frame: Baseline and End of each 12-week intervention phase
Urinary oxylipin levels, including isoprostanes, prostaglandins, and thromboxanes, are quantified in first-morning urine samples using targeted mass spectrometry and normalized to urinary creatinine.
Baseline and End of each 12-week intervention phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Junta de Andalucia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SucroMet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) sharing has not yet been determined. Any future decision to share IPD will depend on additional ethical approvals, data protection regulations (including GDPR), and the terms of the informed consent. If IPD are shared, they will be fully anonymized and made available only for scientifically sound research purposes, subject to appropriate data access agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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