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Heart / cardiovascular disease

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

Recruiting · Ann Arbor, Michigan

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Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

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Your choice

Voluntary — you can stop anytime

What is this study?

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.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • You have a confirmed, stable diagnosis of HFpEF and you are on your heart failure medicines at the maximum tolerated dose without dose changes in the last month.
  • Your left ventricular ejection fraction (how well the heart pumps) was documented as greater than 50% within the last 12 months.
  • You have a confirmed diagnosis of type 2 diabetes (T2DM) with HbA1c less than 10% and no changes to your diabetes medicines in the past month.
  • You are not currently using prebiotics or probiotics.
  • You have not taken certain antibiotics in the past 6 months, and you are not in another interventional clinical trial.

🚫 You may not be able to join if…

  • You currently use pre- or probiotic products.
  • You used antibiotics in the past 6 months.
  • You are in another interventional clinical trial.
  • You have had allergy or certain gut/intestinal diseases (including potato allergy or potato starch allergy, inflammatory bowel syndrome/disease, bowel resection, Roux-en-Y gastric bypass, celiac disease, Crohn’s disease, or colorectal cancer).
  • You had a low blood sugar episode (blood glucose 70 mg/dL) in the last month or you have stage IV–V chronic kidney disease; you are also not allowed if you are pregnant or if you have another condition that limits survival to under 12 months.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 18–any age
  • Have Type 2 diabetes or Heart / cardiovascular disease
  • !Some conditions may not be a fit: Kidney disease
  • !Not for people who are pregnant or breastfeeding

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

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.

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT06337812 · Locations: Michigan