AzTrials
AzTrials

Overweight , ObesityNCT07656298

SucroMet Nutritional Intervention Trial

A study testing Sucrose- Low dose, Sucrose - High Dose and Sucralose - Low Dose in people with Overweight , Obesity and Glucose Metabolism, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight , Obesity, Glucose Metabolism
What is being tested?
Sucrose- Low dose, Sucrose - High Dose and Sucralose - Low Dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
Jul 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Spain1 site, 1 recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, 29103

    Libia Alejandra García Flores, PhD., 0034636938538, libia.garcia@ibima.eu

    Lourdes Garrido Sánchez, PhD., 0034629910317, lourgarrido@gmail.com

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read more

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?
Read the 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.

Being tested
Sucrose- Low dose, Sucrose - High Dose, Sucralose - Low Dose, Sucralose - High Dose
Keywords
Sucrose, Sucralose, Sweeteners, Body Composition, Glucose Metabolism, Gut Microbiota, DNA Methylation, Inflammation, Oxidative Stress Biomarkers, Nutritional Intervention
Medical subject headings
Overweight, Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sucrose- Low doseBehavioural

    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.

  • Sucrose - High DoseBehavioural

    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.

  • Sucralose - Low DoseBehavioural

    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.

  • Sucralose - High DoseBehavioural

    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.

Study groups in NCT07656298
Study groupRoleWhat they receive
Sucrose - Low DoseExperimentalParticipants 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.
Receives: Behavioral: Sucralose - Low Dose
Sucrose - High DoseExperimentalParticipants 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.
Receives: Behavioral: Sucrose - High Dose
Sucralose - Low DoseExperimentalParticipants 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.
Receives: Behavioral: Sucrose- Low dose
Sucralose - High DoseExperimentalParticipants 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.
Receives: Behavioral: Sucralose - High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. Glycemic biomarker

    Change in Hemoglobin A1c (%): Hemoglobin A1c measured as an indicator of long-term glycemic control.

    Measured: Baseline and End of each 12-week intervention phase

  2. Change in Fat Mass

    Fat mass (kg) is assessed using bioelectrical impedance analysis (BIA).

    Measured: Baseline and End of each 12-week intervention phase

  3. Change in Systolic Blood Pressure

    Systolic blood pressure is measured under standardized clinical conditions using validated devices.

    Measured: Baseline and End of each 12-week intervention phase

  4. Change in Triglycerides

    Triglyceride levels (mg/dL) are measured using standard clinical laboratory methods.

    Measured: Baseline and End of each 12-week intervention phase

  5. Change in Relative Abundance of Gut Microbiota

    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.

    Measured: Baseline and End of each 12-week intervention phase

  6. Change in DNA Methylation in Peripheral Blood Mononuclear Cells

    DNA methylation levels are assessed in peripheral blood mononuclear cells (PBMCs) by quantifying methylation at specific CpG sites using bisulfite-based epigenetic analysis techniques.

    Measured: Baseline and End of each 12-week intervention phase

  7. Change in Urinary Oxylipin Levels

    Urinary oxylipin levels, including isoprostanes, prostaglandins, and thromboxanes, are quantified in first-morning urine samples using targeted mass spectrometry and normalized to urinary creatinine.

    Measured: Baseline and End of each 12-week intervention phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07656298
Sponsor's protocol ID
SucroMet
Status last verified
Jun 2026
First submitted
20 Feb 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Sucrose- Low dose, Sucrose - High Dose and Sucralose - Low Dose in people with Overweight , Obesity and Glucose Metabolism, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Libia Alejandra Garcìa Flores, PhD. ((+34) 951 440 260, libia.garcia@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HOMA-IR Index (time frame: Baseline (before intervention) and End of each 12-week intervention phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07656298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in