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SucroMet Nutritional Intervention Trial

15 июня 2026 г. обновлено: 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?

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

120

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Libia Alejandra Garcìa Flores, PhD.
  • Номер телефона: (+34) 951 440 260
  • Электронная почта: libia.garcia@ibima.eu

Учебное резервное копирование контактов

  • Имя: José Manuel García Almeida, MD, PhD.
  • Номер телефона: (+34) 951032244
  • Электронная почта: jgarciaalmeida@uma.es

Места учебы

  • Испания
    • Malaga
      • Málaga, Malaga, Испания, 29103
        • Рекрутинг
        • Hospital Universitario Virgen de la Victoria
        • Контакт:
          • Libia Alejandra García Flores, PhD.
          • Номер телефона: 0034636938538
          • Электронная почта: libia.garcia@ibima.eu
        • Контакт:
          • Lourdes Garrido Sánchez, PhD.
          • Номер телефона: 0034629910317
          • Электронная почта: lourgarrido@gmail.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Фундаментальная наука
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: 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.
Экспериментальный: 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.
Поведенческий: 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.
Экспериментальный: 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.
Поведенческий: 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.
Экспериментальный: 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.
Поведенческий: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in HOMA-IR Index
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Glycemic biomarker
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

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

Соавторы

Junta de Andalucia

Следователи

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

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июля 2026 г.

Первичное завершение (Оцененный)

1 июля 2027 г.

Завершение исследования (Оцененный)

1 сентября 2027 г.

Даты регистрации исследования

Первый отправленный

20 февраля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

15 июня 2026 г.

Первый опубликованный (Действительный)

18 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • SucroMet

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Sucralose - Low Dose

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