The Metabolic Effects of Oral Tributyrin Administration

Официальное название

The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals

Обзор

The goal of this double-blinded randomized clinical cross-over trial is to investigate the metabolic and appetite regulating effects of oral tributyrin (a butyrate pro-drug) administration vs placebo. The main questions it aims to answer are: * Does tributyrin have glucose lowering properties in humans? * Does tributyrin reduce appetite in humans? A sample size calculation estimated a minimum of 10 participants. We expect to include 12 participants in this study. Tributyrin or placebo is ingested once or twice daily for 2x2 weeks, separated by a washout period of minimum 2 weeks. On trial day following each 2-week period we assess: * Postprandial blood sugar levels * Hunger sensations (questionnaire) * Enteroendocrine hormone secretion (GLP-1, GIP, PYY, LEAP2, ghrelin) * Cardiac function (echocardiography) - An exploratory study evaluating the hemodynamic effects assessed by echocardiography is anticipated to be published separately. * Caloric intake (ad libitum meal test) * Gastric emptying rate (acetaminophen test) * Resting metabolic rate (indirect calorimetry). While at home, subjects will wear a sleep monitoring device for three consecutive nights and deliver fecal samples for analysis of short-chain fatty acid content and microbiota composition.

Вмешательства

• Пищевая добавка tributyrin
  Oral ingestion of tributyrin (liquid) once daily (20 g x 1) for 7 days, then twice daily (20 g x 2) for 7 days.
• Пищевая добавка Control
  Oral ingestion of water (liquid) with added bitter substance once daily (20 ml x 1) for 7 days, then twice daily (20 ml x 2) for 7 days

Первичные конечные точки

• Postprandial glucose [Срок оценки: During trial day, time 120-300 minutes]

Вторичные конечные точки (12)

• Butyrate [Срок оценки: During trial day, time 0-300 minutes]
• Subjective appetite - appetite questionaire [Срок оценки: 0, 60, 120, 180, 240, 300 minutes]
• Caloric intake [Срок оценки: Time 300 minutes]
• Gastric emptying assessed by acetaminophen [Срок оценки: From ingestion of mixed meal test with acetaminophen, time 120-240 minutes]
• GLP-1 [Срок оценки: During trial day, time 0-300 minutes]
• GIP [Срок оценки: During trial day, time 0-300 minutes]
• LEAP2 [Срок оценки: During trial day, time 0-300 minutes]
• PYY [Срок оценки: During trial day, time 0-300 minutes]
• Ghrelin [Срок оценки: During trial day, time 0-300 minutes]
• Insulin [Срок оценки: During trial day, time 0-300 minutes]
• C-peptide [Срок оценки: During trial day, time 0-300 minutes]
• Glucagon [Срок оценки: During trial day, time 0-300 minutes]

Критерии участия

Критерии включения

• A body mass index (BMI) between 30-45 kg/m2
• Older than 18 years of age
• HbA1c < 48 mmol/mol
• Hemoglobin within normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)
• Written and oral consent to participate

Критерии исключения

• Medications affecting glucose metabolism and/or appetite (e.g. insulin, metformin, GLP-1 analogues)
• Special diet (HCLF, ketogenic diets, vegan/vegetarian)
• Ongoing cancer or other acute/chronic serious diseases (determined by PI)
• Inability to understand Danish or English
• Abnormal blood samples at screening visit (determined by PI and co-investigators)
• Deemed unsuitable to participate by the PI and co-investigators

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Дания · 1 центр

• SDCA / Medical Research Laboratory — Aarhus N

Идентификаторы

NCT: NCT07463495 · 1-10-72-110-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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