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SucroMet Nutritional Intervention Trial

15 czerwca 2026 zaktualizowane przez: 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?

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Libia Alejandra Garcìa Flores, PhD.
  • Numer telefonu: (+34) 951 440 260
  • E-mail: libia.garcia@ibima.eu

Kopia zapasowa kontaktu do badania

  • Nazwa: José Manuel García Almeida, MD, PhD.
  • Numer telefonu: (+34) 951032244
  • E-mail: jgarciaalmeida@uma.es

Lokalizacje studiów

  • Hiszpania
    • Malaga
      • Málaga, Malaga, Hiszpania, 29103
        • Rekrutacyjny
        • Hospital Universitario Virgen de la Victoria
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in HOMA-IR Index
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Glycemic biomarker
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

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

Współpracownicy

Junta de Andalucia

Śledczy

  • Główny śledczy: Libia Alejandra García Flores, PhD, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
  • Główny śledczy: José Manuel García Almeida, MD, PhD., Andaluz Health Service

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2027

Ukończenie studiów (Szacowany)

1 września 2027

Daty rejestracji na studia

Pierwszy przesłany

20 lutego 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

18 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SucroMet

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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