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Идёт набор NCT07213245

Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF)

Без фазы С лечением Appetite Obesity and Obesity-related Medical Conditions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Meal high in energy density, high in ultra-processed food, Meal high in energy density, low in ultra-processed food, Meal low in energy density, high in ultra-processed food, Meal low in energy density, low in ultra-processed food.
Кому может быть актуально
Состояния в реестре: Appetite, Obesity and Obesity-related Medical Conditions. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
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Официальное название

Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF): a Randomized Controlled Trial

Обзор

The overall aim of this project is to study the effects of short-term high ultra-processed food intake, compared to nutrient- and energy density matched low ultra-processed food (UPF) intake, on energy intake and appetite. A total of 24 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. A randomized 2\*2 factorial four-way crossover study will be conducted at the Department of Internal medicine and Clinical Nutrition at the University of Gothenburg, comparing a high-UPF meal to a low-UPF meal also with high and/or low energy density. A supervised breakfast meal will be served, and postprandial blood samples and appetite measures will be collected continuously up to 4 hours after the breakfast meal. Subsequently, an ad libitum lunch meal will be served, and energy intake will be recorded.

Вмешательства

  • Другое Meal high in energy density, high in ultra-processed food
    Meal high in energy density, high in ultra-processed food
  • Другое Meal high in energy density, low in ultra-processed food
    Meal high in energy density, low in ultra-processed food
  • Другое Meal low in energy density, high in ultra-processed food
    Meal low in energy density, high in ultra-processed food
  • Другое Meal low in energy density, low in ultra-processed food
    Meal low in energy density, low in ultra-processed food

Первичные конечные точки

  • Self-reported appetite [Срок оценки: Baseline to 8 hours after test meal]
  • Energy intake [Срок оценки: 4 hours after test meal]
  • Gastrointestinal hormones - incretins [Срок оценки: Baseline to 4 hours after test meal]
  • Gastrointestinal hormones - cholecystokinin [Срок оценки: Baseline to 4 hours after test meal]
  • Gastrointestinal hormones - peptide YY [Срок оценки: Baseline to 4 hours after test meal]
  • Gastrointestinal hormones - ghrelin [Срок оценки: Baseline to 4 hours after test meal]
Вторичные конечные точки (11)
  • Eating rate [Срок оценки: Baseline til end of study meal]
  • Glucose postprandial [Срок оценки: Baseline to 4 hours after test meal]
  • Insulin postprandial [Срок оценки: Baseline to 4 hours after test meal]
  • Lipid metabolism [Срок оценки: Baseline to 4 hours after test meal]
  • Metabolome [Срок оценки: Baseline to 4 hours after test meal]
  • Proteome [Срок оценки: Baseline to 4 hours after test meal]
  • Self-reported prospective energy intake [Срок оценки: From 30 min until midnight or bedtime (which ever comes first)]
  • Inflammatory markers in blood - cytokines [Срок оценки: Baseline to 4 hours after test meal]
  • Inflammatory markers in blood - lipopolysaccharides [Срок оценки: Baseline to 4 hours after test meal]
  • Inflammatory markers in blood - GlycA [Срок оценки: Baseline to 4 hours after test meal]
  • Lipid profile [Срок оценки: Baseline to 4 hours after test meal]

Критерии участия

Критерии включения

  • Body mass index (BMI) 18.5-30 kg/m2
  • Fasting glucose < 6.1 mmol/l
  • Hb >110 g/L
  • Weight stability the last 3 months +/-5%

Критерии исключения

  • Food allergies, intolerances or preferences preventing consumption of any products included in the study.
  • Unable to sufficiently understand written and spoken Swedish or English to provide written consent and understand information and instructions from the study personal.
  • Pregnant, lactating or planning a pregnancy during the study period.
  • Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
  • History of gastrointestinal conditions or major gastrointestinal surgery (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.).
  • Type 1 diabetes or type 2 diabetes.
  • Thyroid disorder.
  • Current smoking, vaping.
  • Following any weight reduction program or having followed one during the last 6 months prior to screening.
  • Not habitually eating breakfast (<5 times/week).
  • Restrained eating based on the three-factor eating questionnaire.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Швеция · 1 центр
  • Department of internal medicine and clinical nutrition, University olf Gothenburg — Gothenburg

Идентификаторы

NCT: NCT07213245 · MEST-UPF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗