Resistant Potato Starch for Gulf War Syndrome

Overseen By Ashley E Kates, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Must not be taking: Probiotics, Antibiotics, Immunomodulatory, Antacids

Disqualifiers: COVID-19, Smoking, Alcohol abuse, 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: Unknown

Duration: 4 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if resistant potato starch, a special type of dietary fiber, can improve the quality of life for Veterans with Gulf War Illness (GWI). GWI often leads to pain, fatigue, stomach troubles, and respiratory problems. Researchers believe gut health might help manage these symptoms. The trial will compare the effects of this fiber supplement to a regular diet. Veterans with moderate to severe GWI symptoms, including fatigue for at least six months and gut-related issues, might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as prebiotics, probiotics, fiber supplements, antibiotics, anti-diarrheal agents, stool softeners, immunomodulatory medications, and medications that suppress gastric acid, at least 30 days before participating.

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

Research shows that resistant potato starch is generally safe for use. Studies have found it rarely causes negative side effects, meaning most people don't experience problems when taking it. As a type of dietary fiber, resistant potato starch functions as a prebiotic, nourishing beneficial gut bacteria. This can improve gut health. These findings suggest that resistant potato starch is safe for humans, including those with Gulf War Illness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Gulf War Illness?

Unlike the standard treatments for Gulf War Syndrome, which often include medications like pain relievers and antidepressants, resistant potato starch offers a unique approach by focusing on gut health. This prebiotic is designed to enhance the growth of beneficial gut bacteria, potentially leading to improved overall health and symptom relief. Researchers are excited about this treatment because it leverages the gut-brain axis, a novel mechanism that could address the condition's root causes rather than just managing symptoms. Additionally, resistant potato starch is a naturally derived substance, which might offer a gentler, more holistic alternative with fewer side effects compared to traditional medications.

What evidence suggests that resistant potato starch might be an effective treatment for Gulf War Syndrome?

Research has shown that eating resistant potato starch can alter the gut microbiota, the group of tiny organisms living in the intestines. These changes have been linked to improved bowel symptoms. This trial will test resistant potato starch as a prebiotic treatment for Gulf War Illness (GWI). Participants in the prebiotic arm will consume resistant potato starch daily for four weeks. Although specific data on GWI is limited, the potential of resistant potato starch to enhance gut health offers a hopeful treatment option. ^{1 2 3 4 5}

Who Is on the Research Team?

Nasia Safdar, MD PhD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Are You a Good Fit for This Trial?

This trial is for Veterans aged 45-80 with moderate to severe Gulf War Illness (GWI) symptoms, including pain, gastrointestinal issues, and fatigue. Participants must be able to consent, take oral medication, provide samples, and comply with study procedures for the duration of the study. Smokers, heavy drinkers, pregnant women or those planning pregnancy are excluded.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

Ability to provide informed written consent

Willing to provide blood and stool samples

Exclusion Criteria

I have been diagnosed with an inflammatory bowel condition.

I do not have lupus, MS, schizophrenia, am not undergoing active cancer treatment, have no stroke-related impairments, and my diabetes is under control.

Involvement in another clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either take a RS prebiotic daily for 4 weeks or maintain their usual diet

4 weeks

Weekly visits for sample collection and questionnaires

Follow-up

Participants are monitored for changes in gut microbiome, SCFA concentrations, and quality of life

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Resistant Potato Starch

Trial Overview The trial is testing Resistant Potato Starch as a dietary fiber prebiotic supplement to improve life quality in Veterans by targeting gut microbiota alterations associated with GWI. The effectiveness will be measured through changes in health-related quality of life indicators.

How Is the Trial Designed?

Group I: Prebiotic arm Experimental Treatment 1 Intervention

Subjects will consume the RS prebiotic daily for 4 weeks. A dose escalation will be used with subjects taking 4g of the prebiotic for the first 4 days, 7g the next 3 days and the full dose of 10g on day 8.

Group II: Standard diet Active Control 1 Intervention

Subjects randomized to this arm will be asked to maintain their usual diet.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

A study analyzed 70 grain-based foods and found that total dietary fiber content varied significantly, ranging from 0.9% to 18.6%, with resistant starch making up a substantial portion of this fiber.

In many bread products and breakfast cereals, resistant starch accounted for over one-third of the total fiber, highlighting its potential importance in dietary fiber intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of resistant starch in selected grain-based foods. Gelroth, JA., Ranhotra, GS., Gelroth, JA., et al.[2019]

Resistant starch has gained popularity in food products over the past decade, being used in staple foods like bread and cereals, as well as in specialized foods for individuals with medical conditions such as celiac disease and ulcerative colitis.

Unlike traditional dietary fibers, resistant starch offers additional health benefits while maintaining appealing taste and texture, which may encourage greater consumption of healthier food options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications and uses of resistant starch. Brown, IL.[2022]

Resistant starch (RS) is gaining attention for its potential health benefits and role as a dietary fiber source, particularly in adults, highlighting its importance in nutrition.

The review discusses various types of RS, factors affecting their formation, and their functional properties in food applications, suggesting that RS can enhance the nutritional value of diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistant Starch-A Review. Sajilata, MG., Singhal, RS., Kulkarni, PR.[2021]

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]

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]

Mice fed a diet high in resistant potato starch (RPS) showed increased susceptibility to bacterial-induced colitis, with higher levels of infection and colonization by the pathogen Citrobacter rodentium compared to those not fed RPS.

The study revealed that high RPS consumption altered the microbiome composition and gene expression in the colon, potentially leading to immunosuppressive effects that could increase vulnerability to gastrointestinal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Raw potato starch alters the microbiome, colon and cecal gene expression, and resistance to Citrobacter rodentium infection in mice fed a Western diet. Smith, AD., Chen, C., Cheung, L., 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]

A high-fiber diet, particularly one including resistant starch (RS) like potato starch, can significantly increase butyrate production in the colon, which may help reverse neoplastic changes and protect against colon cancer.

Different types of resistant starch have varying effects on fecal weight and butyrate levels, with potato starch showing the most significant enhancement of butyrate compared to other starches, suggesting that the source of RS matters for colon health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effects of three resistant starch preparations on transit time and short-chain fatty acid production in rats. Ferguson, LR., Tasman-Jones, C., Englyst, H., et al.[2022]

In a study involving 14 healthy adults, both resistant starch (RS) and wheat bran (WB) significantly increased daily faecal output compared to a low-fibre baseline, with RS increasing output to 164.2 g and WB to 194.5 g.

While both types of fibre improved faecal weight, only wheat bran significantly enhanced faecal consistency, indicating that while RS is effective for increasing output, WB may be better for improving stool quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of resistant starch on laxation in healthy adults. Maki, KC., Sanders, LM., Reeves, MS., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05820893

NCT05820893 | Resistant Potato Starch to Alleviate GWI The investigators will evaluate the effectiveness of a dietary fiber prebiotic supplement intervention on improving the quality of life of Veterans with GWI.

2. trialx.com trialx.com/clinical-trials/listings/320227/resistant-potato-starch-to-alleviate-gwi/

Resistant Potato Starch to Alleviate GWI Longitudinal studies have shown little to no overall improvement in symptoms over time. Currently there are very limited treatment courses for ...

3. clinicaltrial.be clinicaltrial.be/en/details/265494?per_page=100&only_recruiting=0&only_eligible=0

Resistant Potato Starch to Alleviate GWI Longitudinal studies have shown little to no overall improvement in symptoms over time. Currently there are very limited treatment courses for ...

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

Potato Starch – Application in Therapy and Current ... To evaluate effectiveness of potato starch in alleviating Gulf War Illness symptoms. Dosage, 20g once daily for 3 days, then 20g twice daily for about 13 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11600726/

Consumption of resistant potato starch produces changes in ... Consumption of resistant potato starch produces changes in gut microbiota that correlate with improvements in abnormal bowel symptoms: a ...