Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals

Официальное название

Evaluation of the Effects of GLP-1 Formula Liquid Drink on Gut Microbiota Modulation and Blood Glucose Regulation in Prediabetic Populations

Обзор

A clinical human dietary intervention trial was conducted to investigate the effects of GLP-1 FORMUL liquid supplementation in individuals with prediabetes or obesity, with a focus on improvements in glycemic and lipid parameters, body composition, and gut microbiota profiles.

Подробное описание

This 12-week randomized, placebo-controlled clinical trial aims to evaluate the nutritional and metabolic effects of GLP-1 FORMULA liquid supplementation. A total of 100 adult participants will be recruited and randomly assigned to one of two groups: (1) placebo group (n = 50), and (2) GLP-1 FORMULA group (n = 50). Participants will consume one bottle (50 g) of either GLP-1 FORMULA or placebo 30 minutes prior to their first meal each day for 8 weeks, followed by a 4-week post-intervention observation period.

Throughout the study, participants will undergo nutritional assessments including body composition analysis, waist-to-hip ratio measurements, appetite rating scales, gastrointestinal symptom questionnaires, and the Patient Health Questionnaire. Additionally, oral glucose tolerance tests (OGTT), standard blood biochemistry analyses, and fecal sample collection will be conducted at designated time points to evaluate glycemic control, metabolic markers, and gut microbiota composition.

Вмешательства

• Пищевая добавка GLP-1 formula liquid drink
  One glass jar (50 g) of the GLP-1 formula liquid drink was administered once daily, 30 minutes prior to the first meal of the day.
• Пищевая добавка Placebo
  One glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day.

Первичные конечные точки

• Change from baseline in BMI at weeks 8 and 12 [Срок оценки: Week 0, 8 and 12]

Вторичные конечные точки (1)

• Change from baseline in blood glucose at weeks 8 and 12 [Срок оценки: Week 0, 8 and 12]

Критерии участия

Критерии включения

• Adults aged 18 to 70 years.
• Clinically diagnosed with prediabetes (fasting plasma glucose: 100-125 mg/dL or HbA1c: 5.7-6.4%) or with a body mass index (BMI) of 25-34.9 kg/m², male or female.
• Have not participated in similar clinical studies within the past three months.
• Able to comprehend the informed consent form, including the study procedures, potential risks, and benefits, and able to provide written informed consent.

Критерии исключения

• Diagnosed with autoimmune diseases or cancer.
• Diagnosed with gastrointestinal chronic diseases such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, celiac disease, bowel control disorders, fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, ulcerative colitis, lactose intolerance, or chronic diarrhea.
• History of gastrointestinal surgery.
• Planning pregnancy in the near future (including male partners), currently pregnant, or breastfeeding women.
• Known allergy or hypersensitivity to probiotics or any of the study product ingredients.
• History of major psychiatric disorders.
• History of substance abuse or alcohol dependency.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Тайвань · 1 центр

• Chung Shan Medical University — Taichung

Идентификаторы

NCT: NCT07089732 · CS2-24199

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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