Fermented Food Diet for Microbiome Balance

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Monoamine oxidase inhibitors

Disqualifiers: Dementia, Schizophrenia, Organ transplant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers are doing this study to find out if a high fermented food diet is tolerable, and if it will help improve quality of life after surviving a critical illness, including severe COVID-19, by promoting gut health recovery and decreasing gut inflammation.

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 exclude those taking Monoamine oxidase inhibitors (a type of antidepressant).

What data supports the effectiveness of the treatment Fermented Food Diet for Microbiome Balance?

Research shows that a high-fermented-food diet can increase the diversity of gut bacteria and reduce inflammation, which are important for a healthy immune system. Fermented foods have been linked to positive effects on gut health and may improve the body's response to certain treatments, like those for cancer, by altering the gut microbiome. ^{1 2 3 4 5}

Is the Fermented Food Diet generally safe for humans?

Fermented foods have been consumed for thousands of years and are generally considered safe, but there can be risks if they are made under poor hygiene conditions, which can lead to the presence of harmful bacteria. It's important to ensure that fermented foods are prepared and stored properly to avoid potential health risks. ^{2 3 6 7 8}

How does the fermented food diet treatment differ from other treatments for microbiome balance?

The fermented food diet is unique because it introduces a diverse range of beneficial microorganisms and bioactive compounds that can directly interact with and enhance the gut microbiome, increasing its diversity and reducing inflammation. Unlike other treatments, it leverages natural fermentation processes to provide both immediate and long-term benefits to gut health. ^{1 2 3 4 9}

Research Team

Lioudmila Karnatovskaia, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for people who've been critically ill, including severe COVID-19 cases, and spent time in the ICU. They should be at risk of long-term mental health issues but can't have dementia or severe cognitive impairment. Participants must speak English, eat normally, not be severely immunosuppressed or on certain medications like MAO inhibitors.

Inclusion Criteria

You have recently been very sick, such as with severe COVID, spent a long time in the intensive care unit, and have ongoing health problems related to your illness.

My cognitive function is good enough to understand and follow study instructions.

Exclusion Criteria

I cannot eat by mouth or have conditions that make certain diets risky.

You are not expected to survive your time in the hospital.

You have a history of memory and thinking problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants incorporate a high fermented food diet into their routine to evaluate its effect on microbiome diversity and mental health

12 weeks

Regular follow-ups at baseline and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fermented Food Diet

Trial Overview The study tests if a diet rich in fermented foods can improve life quality after critical illness by aiding gut health and reducing inflammation. It's aimed at those recovering from serious conditions such as COVID-19 to see if this dietary change could help with physical and mental recovery.

Participant Groups

Group I: Fermented Foods Diet Experimental Treatment 1 Intervention

Subjects will incorporate fermented food into their diet.

Group II: Normal Diet Active Control 1 Intervention

Subjects will continue their regular diet.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A 17-week study with 36 healthy adults showed that a high-fiber diet increased specific enzymes in the gut microbiome but did not change overall immune response, indicating a complex relationship between diet and immune function.

In contrast, a diet rich in fermented foods improved microbiome diversity and reduced inflammation, suggesting that such foods could help combat the negative effects of low diversity and high inflammation common in modern diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut-microbiota-targeted diets modulate human immune status. Wastyk, HC., Fragiadakis, GK., Perelman, D., et al.[2022]

Fermentation processes, both in food production and the gastrointestinal tract, produce compounds that can significantly impact consumer health, highlighting the importance of selecting specific food-fermenting microbes to enhance nutritional value.

The gut microbiota plays a crucial role in generating health-active molecules, and dietary choices can modulate this activity, suggesting that a multidisciplinary approach is essential for understanding how diet and microbes interact to benefit health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of microbial transformation of food on health - from fermented foods to fermentation in the gastro-intestinal tract. van Hylckama Vlieg, JE., Veiga, P., Zhang, C., et al.[2011]

Fermented foods have been part of human diets for nearly 10,000 years and contain unique microorganisms that can positively influence gut health.

These foods can impact the gut microbiome both in the short and long term, making them an important component of a healthy diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented Foods, Health and the Gut Microbiome. Leeuwendaal, NK., Stanton, C., O'Toole, PW., et al.[2022]

The global market for fermented foods is approximately USD 30 billion and is growing, highlighting the increasing popularity and demand for these products.

Fermented foods play a crucial role in health, particularly through their impact on the microbiome, which is essential for maintaining human health and could be tailored for specific dietary needs, such as for patients with Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermentative Foods: Microbiology, Biochemistry, Potential Human Health Benefits and Public Health Issues. Voidarou, C., Antoniadou, Μ., Rozos, G., et al.[2021]

Dietary interventions, particularly through the consumption of fermented foods, may enhance the gut microbiome and improve the immune response to cancer immunotherapies, potentially leading to better cancer treatment outcomes.

The review highlights the need for more research on how fermented food interventions can be effectively implemented in cancer patients to optimize their treatment and survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut microbiome and cancer implications: Potential opportunities for fermented foods. Crowder, SL., Jim, HSL., Hogue, S., et al.[2023]

Most caregivers in the South African community are aware of fermented foods and their benefits, but many struggle to differentiate between fermented and unfermented foods, indicating a gap in knowledge.

There is a need for education and health promotion campaigns to standardize the preparation of fermented foods, as misconceptions about the fermentation process were common among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

South African rural community understanding of fermented foods preparation and usage. Chelule, PK., Mokgatle, MM., Zungu, LI.[2020]

The expert panel defined fermented foods as those made through specific microbial growth and enzymatic processes, aiming to clarify the term 'fermented' and distinguish these foods from probiotics.

The panel highlighted the health benefits and safety of fermented foods, discussing their nutritional value and potential to improve gastrointestinal and overall health, while also advocating for their recognition in national dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on fermented foods. Marco, ML., Sanders, ME., Gänzle, M., et al.[2021]

Fermentation is a widely used and affordable food preservation method in developing countries, offering benefits like extended shelf life, improved digestibility, and potential health advantages from functional microorganisms.

However, the lack of hygiene standards and quality control in the fermentation process can lead to health risks, including contamination with harmful pathogens, which poses a significant food safety concern, particularly in low-income regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Faces of Fermented Foods-The Benefits and Threats of Its Consumption. Skowron, K., Budzyńska, A., Grudlewska-Buda, K., et al.[2022]

Traditional fermented foods in Africa play a crucial role in food preservation, enhancing nutritional value, and supporting food security, which is vital for socio-economic growth.

Recent studies using advanced DNA sequencing have uncovered diverse microbial populations in these fermented foods that could be leveraged to improve health, food safety, and overall food quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

African fermented foods: overview, emerging benefits, and novel approaches to microbiome profiling. Obafemi, YD., Oranusi, SU., Ajanaku, KO., et al.[2022]

References

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

Gut-microbiota-targeted diets modulate human immune status. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Impact of microbial transformation of food on health - from fermented foods to fermentation in the gastro-intestinal tract. [2011]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Fermented Foods, Health and the Gut Microbiome. [2022]

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

Fermentative Foods: Microbiology, Biochemistry, Potential Human Health Benefits and Public Health Issues. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Gut microbiome and cancer implications: Potential opportunities for fermented foods. [2023]

6. India pubmed.ncbi.nlm.nih.gov

South African rural community understanding of fermented foods preparation and usage. [2020]

7. England pubmed.ncbi.nlm.nih.gov

The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on fermented foods. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Two Faces of Fermented Foods-The Benefits and Threats of Its Consumption. [2022]

9. England pubmed.ncbi.nlm.nih.gov

African fermented foods: overview, emerging benefits, and novel approaches to microbiome profiling. [2022]