Fiber Supplementation to Increase Short Chain Fatty Acid Production in Patients With Type II Diabetes and Heart Failure With Preserved Ejection Fraction - the FERMENT HFpEF Trial

University of Michigan2 个研究点分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新: 2025年7月24日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: University of Michigan
入组人数: 30
试验地点: 2
主要终点: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Health Services Research
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior month)
•Left ventricular ejection fraction of >50% documented in the prior 12 months
•A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin <10% without changes in medical regimen in the past month.

排除标准

•Current usage of pre- or probiotic usage
•Antibiotic usage in the past 6 months
•Current participation in another interventional clinical trial
•History of potato allergy or potato starch allergy, inflammatory bowel syndrome, inflammatory bowel disease, bowel resection, Roux-en-Y gastric bypass surgery, celiac disease, Crohn's disease, or colorectal cancer
•Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dL) within the last month
•Stage IV-V chronic kidney disease
•Pregnancy (self-reported)
•Comorbidity limiting survival to < 12 months