Fiber Supplementation for Heart Failure

Overseen By Scott Hummel, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Potato allergy, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how adding potato starch, a type of dietary fiber, to the diet might alter gut bacteria and produce beneficial substances called short-chain fatty acids. Researchers believe these changes could improve health for individuals with certain heart conditions, specifically those with stable heart failure and normal pumping function who also have type 2 diabetes. Participants who have been stable on heart and diabetes medications for at least a month might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for heart and diabetes patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that your heart failure and diabetes medications have not changed in the past month. It's best to discuss with the study team to understand how your current medications might fit with the trial.

What prior data suggests that potato starch supplementation is safe?

Research shows that potato starch, a type of resistant starch, is generally safe to eat. It provides a good source of dietary fiber, which is important for a healthy diet. Potato starch appears in various diet plans, and major reports of harmful side effects are absent.

Previous studies on dietary fiber, including potato starch, have not raised major safety concerns. In fact, diets high in fiber are linked to better heart health and might help lower the risk of heart problems. This suggests that potato starch is likely safe, especially since it is already used in many foods.

While specific safety data from clinical trials focused solely on potato starch is lacking, its use in other diet studies supports its general safety. Serious safety issues likely would have been reported by now if they existed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for heart failure focus on medications that manage symptoms, like ACE inhibitors or beta-blockers. But potato starch supplementation is unique because it taps into gut health by increasing dietary fiber, which may help reduce inflammation and improve heart function. Researchers are excited about this treatment because it offers a natural, potentially low-risk alternative to traditional medications, with the added benefit of being easily incorporated into daily diets. This approach could complement existing therapies and provide a novel way to support heart health.

What evidence suggests that potato starch might be an effective treatment for heart failure?

Research has shown that potato starch, a type of resistant starch, benefits heart health. Studies indicate that resistant starch aids the body in processing carbohydrates and fats, which are crucial for a healthy heart. It also acts as a prebiotic, supporting the growth of beneficial gut bacteria. This can lead to the production of short-chain fatty acids, which may reduce inflammation—a key factor in heart disease. Additionally, increased dietary fiber intake, such as potato starch, has been linked to a lower risk of mortality from heart problems in heart failure survivors. Overall, potato starch might improve heart health by enhancing gut health and reducing inflammation. ^{6 7 8 9 10}

Who Is on the Research Team?

Scott Hummel, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with heart failure that still have a normal amount of blood pumped from their heart (HFpEF) and also have type 2 diabetes. Participants should be interested in adding dietary fiber to their diet.

Inclusion Criteria

Left ventricular ejection fraction of >50% documented in the prior 12 months

I have stable heart failure with preserved ejection fraction and have been on a steady heart failure medication regimen.

I have Type II diabetes with stable treatment and my HbA1c is below 10%.

Exclusion Criteria

Antibiotic usage in the past 6 months

Pregnancy (self-reported)

Current participation in another interventional clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will take a potato starch supplement to increase dietary fiber for approximately 4 weeks

4 weeks

Follow-up

Participants are monitored for changes in short chain fatty acid levels in plasma and stool

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Potato Starch

Trial Overview The study is testing the effects of potato starch as a dietary supplement on gut bacteria and its byproducts in people with HFpEF and type 2 diabetes. The goal is to see if this can produce more beneficial fatty acids for health.

How Is the Trial Designed?

Group I: Potato starch supplement Experimental Treatment 1 Intervention

Participants will take the supplement for approximately 4 weeks.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

FiberBind 400, a commercial potato fiber product, significantly improved the survival of specific probiotic Lactobacillus strains under simulated gastric conditions, particularly enhancing the survival of L. fermentum PCC® and L. rhamnosus LGG®.

Fermentation of FiberBind 400 led to a more diverse gut microbiota composition compared to starches, promoting beneficial bacterial genera while selectively modulating gut populations, indicating its potential as a functional food ingredient with health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of potato fiber on survival of Lactobacillus species at simulated gastric conditions and composition of the gut microbiota in vitro. Larsen, N., de Souza, CB., Krych, L., et al.[2020]

In a study involving male Sprague-Dawley rats, dietary gelatinized potato starch, particularly from the Hokkaikogane cultivar, significantly reduced serum free fatty acids and triglycerides, indicating potential benefits for lipid metabolism.

The research suggests that while potato starch can lower triglyceride levels in the serum and liver, it does not influence cecal fermentation, highlighting its specific effects on lipid metabolism without altering gut fermentation processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestion of gelatinized potato starch containing a high level of phosphorus decreases serum and liver lipids in rats. Kanazawa, T., Atsumi, M., Mineo, H., et al.[2019]

In a study investigating the effects of uncooked potato starch in the diet of rats, a 25% potato starch diet significantly increased cecal size and the production of volatile fatty acids, which are important for energy metabolism.

The diet did not alter blood glucose or lactate levels but increased blood acetate while reducing plasma triglycerides and cholesterol, suggesting that potato starch may positively influence metabolic health similar to dietary fibers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of unrefined potato starch on cecal fermentations and volatile fatty acid absorption in rats. Demigne, C., Remesy, C.[2018]

In a study involving 12 male Yorkshire pigs, daily supplementation with 10g of resistant starch (RS) for 30 days significantly improved insulin sensitivity and lowered fasting serum glucose levels by 20%, indicating potential benefits for diabetes management.

The RS group also showed a 28% increase in total high-density lipoprotein (HDL) particles, particularly in the small HDL subclass, suggesting that RS may aid in lipid management by enhancing beneficial cholesterol levels without affecting overall cholesterol or triglyceride levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Resistant Starch Supplementation Increases High-Density Lipoprotein Particle Number in Pigs Fed a Western Diet. Rideout, TC., Harding, SV., Raslawsky, A., et al.[2022]

In a study involving rats, potato starch from Snowden and Kitahime varieties improved cecal fermentation by increasing beneficial short-chain fatty acids and lowering cecal pH compared to a control group.

The consumption of potato starch also enhanced immune function by raising cecal immunoglobulin A levels and reducing harmful compounds like ammonia-nitrogen and indole, suggesting potential health benefits for gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Raw Potato Starch with High Resistant Starch Levels on Cecal Fermentation Properties in Rats. Nagata, R., Innami, N., Pelpolage, S., et al.[2020]

Rats fed diets containing various colored potato flakes (white, red, and purple) showed significant improvements in cecal health, including lower cecal pH and higher concentrations of short-chain fatty acids (SCFAs) compared to those on a control diet, indicating enhanced fermentation and beneficial gut bacteria activity.

The study found that the consumption of purple potato flakes led to increased fecal excretion of total and secondary bile acids, suggesting that these potato flakes may positively influence bile acid metabolism and overall colonic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding potato flakes affects cecal short-chain fatty acids, microflora and fecal bile acids in rats. Han, KH., Hayashi, N., Hashimoto, N., et al.[2018]

In a study with 38 healthy adults, nutritional bars containing resistant starch type-4 (VERSAFIBE™ 1490) significantly reduced post-meal blood sugar and insulin levels compared to a control bar, indicating improved glycemic control.

Both medium and high fiber bars led to lower capillary glucose and venous insulin responses, suggesting that increasing dietary fiber through resistant starch can have beneficial effects on metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Bar with Potato-Based Resistant Starch Attenuated Post-Prandial Glucose and Insulin Response in Healthy Adults. Gourineni, V., Stewart, ML., Wilcox, ML., et al.[2020]

Rats fed raw potato powder (RP) showed significantly higher levels of resistant starch and beneficial lactic acid bacteria compared to those on a control diet, indicating that RP may enhance gut health.

The RP group also had lower cecal pH and higher concentrations of short-chain fatty acids (SCFAs), suggesting that raw potato powder can positively influence intestinal fermentation and microbial activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. Kawakami, S., Han, KH., Araki, T., et al.[2018]

Acrylamide, a harmful substance found in many foods, negatively affects the structure and function of the small intestinal wall in mice, leading to reduced absorption and increased cell damage.

Dietary potato fiber preparations can completely counteract the harmful effects of acrylamide on the small intestine, suggesting a protective role without affecting acrylamide levels in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potato fiber protects the small intestinal wall against the toxic influence of acrylamide. Dobrowolski, P., Huet, P., Karlsson, P., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12018438/

Association between dietary fiber intake and all-cause ... A higher dietary fiber intake was associated with a lower risk of all-cause and CVD-caused mortality in HF survivors, especially in male patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11819994/

The Impact of Dietary Fiber on Cardiovascular Diseases Some dietary fibers could reduce inflammation, a risk factor for coronary heart disease. High-fiber diets also help with weight management, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1756464622001645

Health benefits of resistant starch: A review of the literature Resistant starch may improve carbohydrate and lipid metabolism and body weight. Resistant starch as a prebiotic improves intestinal function.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0271531723000246

Resistant starch improves cardiometabolic disease outcomes Healthy dietary patterns with adequate fiber improve cardiometabolic (CM) outcomes and attenuate disease progression. Resistant starch (RS) is a fermentable ...

5. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.101465

Dietary Interventions in Heart Failure With Preserved ... This scoping review will examine available evidence regarding dietary interventions in patients with HFpEF, highlight existing gaps in knowledge, and discuss ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286324001979

Resistant starch confers protection of dietary against ... Resistant starch confers protection of dietary against diabetic cardiomyopathy ... heart failure with preserved ejection fraction (HFpEF). HFpEF accounts for ...

7. ift.onlinelibrary.wiley.com ift.onlinelibrary.wiley.com/doi/10.1111/1541-4337.12955

Resistant starch—An accessible fiber ingredient acceptable to ... Increased consumption of processed food has led to a reduction in average dietary fiber intakes and an associated chronic disease prevalence.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9268622/

Therapeutic Benefits and Dietary Restrictions of Fiber Intake A diet rich in cereals, fruits, vegetables and nuts, according to the study, lowers the risk of mortality from a heart attack in people at high risk of coronary ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X24007452

Dietary Interventions in Heart Failure With Preserved ... Patients in the intervention group had modest improvement in disease-related quality of life (+3.38 points adjusted difference in Kansas City Cardiomyopathy ...

10. clinicaltrials.eu clinicaltrials.eu/inn/potato-starch/

Potato Starch – Application in Therapy and Current ... Immune Checkpoint Inhibitors (ICIs): A type of cancer treatment that helps the immune system recognize and attack cancer cells more effectively. Gulf War ...