Resistant Potato Starch for Liver Cirrhosis

Overseen By Max Macgregor

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: Antibiotics, Lactulose

Disqualifiers: Hospitalization, Refractory ascites, Alcohol, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a dietary supplement made from resistant potato starch affects individuals with liver cirrhosis, particularly those who have experienced confusion or memory problems (hepatic encephalopathy). The goal is to determine if the potato starch can beneficially alter gut bacteria. Participants will take the starch for four weeks, and researchers will collect health information and stool samples to study the effects. This trial suits those diagnosed with cirrhosis who have had at least one episode of confusion or memory issues in the past year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow the use of rifaximin and excludes recent use of certain antibiotics and lactulose. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that resistant potato starch is likely to be safe for humans?

Research has shown that resistant potato starch is safe for use. In one study, participants who took it daily found it safe and easy to continue using. They adhered to the treatment well and did not report any major problems.

Resistant potato starch is known to improve gut health. It can alter gut bacteria types and enhance the immune system's function in the gut. This helps the body deal with germs more effectively without causing harm. Overall, studies suggest that resistant potato starch is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cirrhosis?

Unlike the standard treatments for liver cirrhosis, which typically involve medications like diuretics and beta-blockers to manage symptoms, resistant potato starch offers a nutritional approach. This starch acts as a prebiotic, feeding beneficial gut bacteria and possibly improving gut health, which can be crucial for liver function. Researchers are excited because it targets the gut-liver axis, a novel approach that may help reduce complications associated with cirrhosis while being a simple dietary addition.

What evidence suggests that resistant potato starch might be an effective treatment for liver cirrhosis?

Studies have shown that resistant potato starch can benefit health. It may help the body process carbohydrates and fats more efficiently, potentially influencing weight and overall well-being. Some research suggests it acts as a prebiotic, improving gut health by nourishing beneficial bacteria. In individuals with liver issues, resistant starch has been linked to reduced inflammation. This trial will evaluate the effects of resistant potato starch on liver cirrhosis, as inflammation poses a significant problem in liver diseases. ^{1 2 3 4 6}

Who Is on the Research Team?

Patricia Bloom, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with liver cirrhosis and overt hepatic encephalopathy, which is a decline in brain function due to severe liver disease. Participants should be willing to consume resistant potato starch and provide health information as well as stool samples for research purposes.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

I have been diagnosed with cirrhosis.

I have had a serious episode of brain dysfunction due to liver disease in the last year.

Exclusion Criteria

Alcohol or illicit drug intake in the last 4 weeks by history characterized as >1 alcoholic drink / week

I have been diagnosed with dementia or another cognitive disorder.

Total bilirubin in the last 3 months > 4 mg/dL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take resistant potato starch for four weeks to study its effects on gut bacteria and health-related outcomes

4 weeks

Baseline visit, weekly monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and study activity completion

4 weeks

End of treatment visit, follow-up at week 8

What Are the Treatments Tested in This Trial?

Interventions

• Resistant Potato Starch

Trial Overview The study is testing the effects of resistant potato starch, a dietary supplement derived from potatoes, on gut bacteria in patients with cirrhosis and hepatic encephalopathy. The goal is to understand how this food product influences the body's response.

How Is the Trial Designed?

Group I: Resistant potato starch Experimental Treatment 1 Intervention

This will be taken for four weeks by enrolled participants.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A feasibility study involving 10 adults showed that daily intake of resistant potato starch (RPS) from day -7 to day 100 after allogeneic hematopoietic stem cell transplantation significantly increased fecal butyrate levels, indicating a positive impact on gut health (P < 0.0001).

The study also found that RPS led to more stable plasma metabolites in participants compared to historical controls, suggesting potential benefits for metabolic health post-transplant, and a phase 2 trial is planned to further investigate its effects on graft-versus-host disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. Riwes, MM., Golob, JL., Magenau, J., et al.[2023]

In a study of 136 subjects with moderate to severe non-alcoholic fatty liver disease (NAFLD), certain dietary patterns were linked to the severity of the condition, revealing that higher intake of winter ice cream and chickpeas was associated with lower NAFLD severity.

Conversely, consumption of rabbit meat, industrial aged cheeses, and milk-based desserts was positively associated with increased NAFLD severity, suggesting that a Mediterranean diet rich in fresh foods and legumes may be beneficial for managing NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Some Food Components on Non-Alcoholic Fatty Liver Disease Severity: Results from a Cross-Sectional Study. Mirizzi, A., Franco, I., Leone, CM., et al.[2020]

In a study of 23,529 participants, higher intake of insoluble dietary fiber (DF) was associated with a lower prevalence of newly diagnosed non-alcoholic fatty liver disease (NAFLD), particularly in men.

DF sources such as whole grains, soy foods, vegetables, and nuts were linked to reduced NAFLD risk, while no significant association was found with soluble DF or fruit intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insoluble dietary fibre intake is associated with lower prevalence of newly-diagnosed non-alcoholic fatty liver disease in Chinese men: a large population-based cross-sectional study. Xia, Y., Zhang, S., Zhang, Q., et al.[2022]

In a study of 372,492 participants over 12 years, a higher adherence to a Western dietary pattern was linked to an increased risk of non-alcoholic fatty liver disease (NAFLD), cirrhosis, and liver cancer, with risks rising by 18%, 21%, and 24% respectively for those in the highest tertile of this diet.

Conversely, a prudent dietary pattern was associated with a 15% lower risk of cirrhosis, suggesting that healthier eating habits may help prevent chronic liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Risk of Non-Alcoholic Fatty Liver Disease, Cirrhosis, and Liver Cancer: A Large Prospective Cohort Study in UK Biobank. Guo, W., Ge, X., Lu, J., et al.[2023]

Supplementing weaned pig diets with at least 0.5% resistant potato starch (RPS) improved fecal scores, indicating better gut health, without negatively affecting growth performance over a 28-day period.

RPS supplementation also lowered digesta pH and increased total volatile fatty acid concentrations in the cecum, suggesting enhanced fermentation and gut function, while maintaining similar visceral organ weights and nutrient digestibility compared to control diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding a diet containing resistant potato starch influences gastrointestinal tract traits and growth performance of weaned pigs. Heo, JM., Agyekum, AK., Yin, YL., et al.[2014]

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]

A study of 6,613 US adults found that higher intakes of total, cereal, fruit, and vegetable fiber are associated with significantly lower odds of developing non-alcoholic fatty liver disease (NAFLD), with the highest fiber intake quartile showing odds ratios as low as 0.12 compared to the lowest quartile.

The relationship between dietary fiber intake and NAFLD risk was found to be non-linear for total fiber but linear for cereal, fruit, and vegetable fibers, indicating that increasing fiber intake from these sources may effectively reduce NAFLD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Dietary Fiber Intake and Non-alcoholic Fatty Liver Disease in Adults. Zhao, H., Yang, A., Mao, L., et al.[2020]

In a 4-week study involving 72 Wistar rats, the addition of 5% resistant starch (RS4) to their diet significantly reduced triacyloglycerol (TAG) levels in the blood serum, indicating a potential benefit for managing fat levels in the body.

However, the total cholesterol (TC) levels in the serum remained unchanged, suggesting that while resistant starch can influence certain lipid profiles, it may not affect overall cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The influence of RS4 resistant starch on wistar rats metabolism. Biochemical and lipid indices]. Figurska-Ciura, D., Orzeł, D., Styczyńska, M., et al.[2013]

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]

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 involving 32 Wistar rats, the addition of resistant starch RS4 to high-fat diets significantly reduced total cholesterol levels by about 25% and triglycerides by approximately 47% in those fed with soybean oil, indicating its beneficial effects on lipid metabolism.

Rats consuming diets with RS4 also showed lower liver damage, as indicated by hepatic enzyme activity, and higher levels of HDL-cholesterol compared to control groups, suggesting improved overall metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. Bronkowska, M., Orzeł, D., Łoźna, K., et al.[2013]

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]

Supplemental nutrition education for 8 patients with cirrhosis undergoing liver transplant evaluation led to a significant increase in their perceived nutrition status, as all patients reported that follow-up phone calls improved their nutrition.

Despite 66.7% of patients experiencing weight loss, the median subjective global assessment score increased, suggesting that the education may have positively influenced their overall nutritional health and adherence to recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Benefit of Supplemental Nutrition Education for Severely Malnourished Patients Awaiting Liver Transplant. Chaney, AJ., Heckman, MG.[2019]

Citations

1. withpower.com withpower.com/trial/phase-2-liver-cirrhosis-5-2024-e226d

Resistant Potato Starch for Liver Cirrhosis A study involving patients who received resistant potato starch daily showed it was feasible and safe, with participants adhering to the treatment and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9159374/

Amelioratory Effect of Resistant Starch on Non-alcoholic Fatty ... It has been found that RS intake reduces fat accumulation to improve insulin sensitivity, thereby maintaining blood glucose levels and lipid metabolic ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9559413/

A randomized clinical trial using smart caps Results confirmed that while resistant starch of approximately 5 g per day improves GI symptoms at 2, 4, and 6 weeks, it did not demonstrate a ...

5. medicalnewstoday.com medicalnewstoday.com/articles/how-resistant-starch-may-help-people-with-nonalcoholic-fatty-liver-disease

Non-alcoholic fatty liver disease: How resistant starch can ... Researchers are reporting that resistant starch may help lower inflammation in people with non-alcoholic fatty liver disease.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06425380/pilot-open-label-trial-of-resistant-potato-starch-in-patients-with-cirrhosis-and-overt-hepatic-encephalopathy

Pilot Open-Label Trial of Resistant Potato Starch in ... This research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut ...