Resistant Potato Starch for Liver Cirrhosis

Recruiting in Palo Alto (17 mi)

Overseen by Patricia Bloom, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Michigan

Must not be taking: Antibiotics, Lactulose

Disqualifiers: Hospitalization, Refractory ascites, Alcohol, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut bacteria of people with cirrhosis and hepatic encephalopathy. The researchers in this study want to understand how potato starch works in the subject's body and how the body will react to it. Along with taking the study product participants health-related information and stool will be collected for this research study.

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.

What data supports the effectiveness of the treatment Resistant Potato Starch for Liver Cirrhosis?

Research suggests that dietary fiber, a component of resistant potato starch, is linked to a lower risk of liver diseases like non-alcoholic fatty liver disease (NAFLD) and cirrhosis. This implies that increasing dietary fiber intake may benefit liver health. ^{1 2 3 4 5}

Is resistant potato starch safe for humans?

A study involving patients who received resistant potato starch daily showed it was feasible and safe, with participants adhering to the treatment and experiencing increased beneficial gut compounds. Other studies in animals suggest potential benefits for gut health, but more human research is needed to confirm safety across different conditions. ^{6 7 8 9 10}

How does resistant potato starch treatment differ from other treatments for liver cirrhosis?

Resistant potato starch is unique because it acts as a dietary fiber that is not digested in the stomach, reaching the large intestine where it promotes the growth of beneficial bacteria and the production of short-chain fatty acids, which can improve gut health. This is different from many traditional treatments for liver cirrhosis that focus on managing symptoms or complications rather than enhancing gut health. ^{6 9 11 12 13}

Research Team

Patricia Bloom, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Resistant Potato Starch (Dietary Supplement)

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.

Participant Groups

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+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Findings from Research

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]

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]

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 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]

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]

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 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 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]

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]

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]

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]

References

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

The Benefit of Supplemental Nutrition Education for Severely Malnourished Patients Awaiting Liver Transplant. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Some Food Components on Non-Alcoholic Fatty Liver Disease Severity: Results from a Cross-Sectional Study. [2020]

3. England 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. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Association Between Dietary Fiber Intake and Non-alcoholic Fatty Liver Disease in Adults. [2020]

5. Switzerland 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. [2023]

9. Poland pubmed.ncbi.nlm.nih.gov

Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. [2013]

10. Japan pubmed.ncbi.nlm.nih.gov

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

11. Poland pubmed.ncbi.nlm.nih.gov

[The influence of RS4 resistant starch on wistar rats metabolism. Biochemical and lipid indices]. [2013]

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

Feeding a diet containing resistant potato starch influences gastrointestinal tract traits and growth performance of weaned pigs. [2014]

13. 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]