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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Potato Starch, Potato Starch, Dietary Fiber for heart failure?

Research shows that resistant starch, a type of dietary fiber found in potato starch, can help lower blood sugar and insulin levels after meals, which may benefit heart health. Additionally, potato starch has been shown to reduce blood fats like triglycerides, which are linked to heart disease. ^{1 2 3 4 5}

Is potato starch or fiber safe for human consumption?

Research on potato starch and fiber in animals suggests they may have beneficial effects on gut health, such as increasing beneficial bacteria and short-chain fatty acids, without indicating any safety concerns. However, these studies were conducted in rats, so human safety data is limited. ^{2 6 7 8 9}

How does potato starch as a treatment for heart failure differ from other treatments?

Potato starch is unique because it acts as a dietary fiber that can improve gut health by increasing beneficial short-chain fatty acids and supporting the growth of good bacteria in the intestines, which may indirectly benefit heart health. Unlike typical heart failure treatments that focus on heart function directly, this approach targets gut health, potentially offering a novel way to support overall cardiovascular health. ^{1 2 3 6 7}

Research Team

Scott Hummel, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Bar with Potato-Based Resistant Starch Attenuated Post-Prandial Glucose and Insulin Response in Healthy Adults. [2020]

2. Japan pubmed.ncbi.nlm.nih.gov

Effects of Raw Potato Starch with High Resistant Starch Levels on Cecal Fermentation Properties in Rats. [2020]

3. Japan pubmed.ncbi.nlm.nih.gov

Ingestion of gelatinized potato starch containing a high level of phosphorus decreases serum and liver lipids in rats. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Dietary Resistant Starch Supplementation Increases High-Density Lipoprotein Particle Number in Pigs Fed a Western Diet. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. [2018]

7. Canada 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Potato fiber protects the small intestinal wall against the toxic influence of acrylamide. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Feeding potato flakes affects cecal short-chain fatty acids, microflora and fecal bile acids in rats. [2018]