Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Potato Starch
  Participants will consume 10 grams (1/2 a packet) of Bob's Red Mill Potato Starch twice a day for the first 7 days and then increase to 20 grams (full packet) of potato starch for approximately 3 weeks. Potato starch can be mixed into cold food or beverage for consumption. In addition, participants will have evaluations and provide blood and stool samples during the study.

Первичные конечные точки

• Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool [Срок оценки: Baseline, approximately 4 weeks]
• Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma [Срок оценки: Baseline, approximately 4 weeks]
• Changes in propionate levels - stool [Срок оценки: Baseline, approximately 4 weeks]
• Changes in propionate levels- plasma [Срок оценки: Baseline, approximately 4 weeks]
• Changes in acetate levels- stool [Срок оценки: Baseline, approximately 4 weeks]
• Changes in acetate levels- plasma [Срок оценки: Baseline, approximately 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06337812 · HUM00240473

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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