Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA ) Medications for Weight Loss
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: inulin (prebiotics), Placebo Comparator: maltodextrin.
- Кому может быть актуально
- Состояния в реестре: Obesity & Overweight. Базовые параметры: 18 лет — 64 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Medications for Weight Loss: a Randomized Double-blind Controlled Trial
Обзор
The goal of this double-blind randomized placebo-controlled supplement study is to investigate if the supplement of inulin (prebiotics, 10 grams per day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) medications for weight loss.
Подробное описание
The goal of this double-blind randomized placebo-controlled supplement study is to investigate if the supplement of inulin (prebiotics, 10 grams per day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) medications. Approximately 600 overweight or obese individuals using GLP-1 RA medications for weight loss will be enrolled. All participants will provide informed consent before randomization. Eligible individuals must be obese or be overweight with at least one body weight-related complications, and have been using GLP-1 RA medications at the time of enrollment for at least 3 months and plan to continue using them in the next 6 months. Eligible participants will be randomly assigned to inulin intervention or placebo group. Randomization will be computed within study center, age and sex groups. The intervention will last for 4 months. Questionnaire data and bio-samples will be collected before the start of intervention and at the end of the intervention. The primary outcomes are lipid levels measured in bio-samples. Data on secondary outcomes will be obtained through biomarker measurement and questionnaires.
Вмешательства
- Пищевая добавка inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months. - Пищевая добавка Placebo Comparator: maltodextrin
The dose is 10 grams per day for 4 months.
Первичные конечные точки
- change in concentrations of blood lipid levels in millimole per liter (mmol/L). [Срок оценки: From enrollment to the end of intervention at 4 months]
Вторичные конечные точки (12)
- change in frequency of gastrointestinal symptoms [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol) [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in level of insulin resistance [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in body weight in kilograms (kg) [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in body fat percentage (%) [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in waist circumference in centimeters (cm) [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in level of gut microbiota abundance [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in level of gut microbiota diversity [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in estimated glomerular filtration rate (eGFR) in milliliter per minute per 1.73 square meters (mL/min/1.73 m²) [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in concentrations of liver function markers in units per liter (U/L) [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in level of C-reactive protein (CRP) in milligram per liter (mg/L) [Срок оценки: From enrollment to the end of intervention at 4 months]
- change in blood pressure in millimeters of mercury (mmHg) [Срок оценки: From enrollment to the end of intervention at 4 months]
Критерии участия
Критерии включения
- Be overweight or obese (meeting any of the following criteria):
- Obesity: BMI >=28 kg/m²;
- Overweight (BMI >= 24 kg/m²) with at least one body weight-related comorbidity: obstructive sleep apnea syndrome, prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia, polycystic ovary syndrome, or non-alcoholic fatty liver disease.
- Must have received GLP-1 RA drugs (Semaglutide, Liraglutide, Benaglutide, Tirzepatide, or Mazdutide) for weight-loss intervention for at least 3 months, and plan to continue using them for the next six months.
- Age 18-64 years.
- Consent to participate and sign the informed consent form.
Критерии исключения
- Currently using non-GLP-1 RA medications for weight-loss, or have undergone or plan to undergo weight-loss procedures within the next 4 months;
- Long-term user of prebiotics or probiotics (excluding fermented dairy products such as yogurt);
- Be allergic or intolerance to inulin-type substances;
- Have participated in in other clinical trials within the past 3 months or are currently participating in other clinical trials;
- Plan to be pregnant within the next year, are currently pregnant, or are breastfeeding;
- Deemed unsuitable for participation by the investigator's judgment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Китай · 5 центров
- The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture — Enshi
- Sinopharm Dongfeng General Hospital — Shiyan
- Huazhong University of Science and Technology — Ухань
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
- Xiangyang No.1 People's Hospital — Xiangyang
Идентификаторы
NCT: NCT07611552 · Prebiotics in GLP-1 RA users