Diet Intervention for Human Microbiome Health

Overseen By Lisa Whisenhunt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska Lincoln

Must not be taking: Antibiotics

Disqualifiers: Cancer treatment, Organ transplant, others

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

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

Trial Summary

What is the purpose of this trial?

The main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken antibiotics or certain medical treatments recently, you may not be eligible to participate.

What data supports the effectiveness of the treatment Food provided from a commercial meal service provider for a week in the clinical trial Diet Intervention for Human Microbiome Health?

Research shows that diet can quickly influence the gut microbiome, with changes observable within days. Short-term dietary changes, like those from a meal service, can lead to significant shifts in gut bacteria, potentially improving gut health. ^{1 2 3 4 5}

Is the diet intervention generally safe for humans?

The research does not provide specific safety data for the diet intervention, but it suggests that dietary changes can affect gut microbiota without mentioning any adverse effects, implying it may be generally safe. ^{1 3 4 5 6}

How does the treatment of food from a commercial meal service provider for a week differ from other treatments for microbiome health?

This treatment is unique because it involves providing meals from a commercial service, which can offer a controlled and consistent diet to study its effects on the gut microbiome. Unlike other treatments that may focus on specific nutrients or supplements, this approach uses whole meals to potentially influence gut health, emphasizing the role of overall dietary patterns rather than individual components. ^{3 4 5 7 8}

Research Team

Jacques Izard, PhD

Principal Investigator

Univeristy of Nebraska-Lincoln

Eligibility Criteria

This trial is for English-speaking individuals who can consent to participate, use an electronic food diary, and eat meals provided by the study. They must have a US address. It's not for those on parenteral nutrition or with allergies to shellfish, insects, carmine, dragon fruit (pitaya), or cacti; anyone treated for cancer or given antibiotics in the last month; or those who've had certain x-rays or bowel preparations recently.

Inclusion Criteria

Able to read and speak English

Only individuals able to provide a US address will be included

Willing to sign consent and have samples collected

Exclusion Criteria

Received oral x-ray contrast within the past 1 month prior to signing consent

You are allergic to cacti.

I have taken antibiotics in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Food Intervention

Participants receive food from a commercial meal service provider to monitor microbiome changes

1 week

Follow-up

Participants are monitored for microbiome composition changes after the food intervention

1 week

Treatment Details

Interventions

• Food provided from a commercial meal service provider for a week

Trial Overview The study tests how different foods affect the human microbiome over time. Participants will consume meals from a commercial service for one week while their microbiome changes are monitored.

Participant Groups

Group I: Food provided Experimental Treatment 1 Intervention

Food provided from a commercial meal service provider for a week

Who Is Running the Clinical Trial?

University of Nebraska Lincoln

Lead Sponsor

Trials

40

Recruited

13,200+

Findings from Research

A study involving 106 subjects over 2 years found that obese patients with severe metabolic disease (MetS-OB) had significant gut microbiome dysbiosis compared to those without metabolic dysfunction and non-obese individuals.

Both Mediterranean and low-fat diets were effective in partially restoring the gut microbiome in obese patients with severe metabolic disease, indicating that dietary interventions can positively impact gut health based on metabolic status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of Two Healthy Dietary Patterns Restored Microbiota Dysbiosis in Obese Patients with Metabolic Dysfunction. Haro, C., García-Carpintero, S., Rangel-Zúñiga, OA., et al.[2018]

References

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

A Guide to Diet-Microbiome Study Design. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Consumption of Two Healthy Dietary Patterns Restored Microbiota Dysbiosis in Obese Patients with Metabolic Dysfunction. [2018]

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

Microbiome Responses to an Uncontrolled Short-Term Diet Intervention in the Frame of the Citizen Science Project. [2022]

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

Daily Sampling Reveals Personalized Diet-Microbiome Associations in Humans. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating Dietary Data into Microbiome Studies: A Step Forward for Nutri-Metaomics. [2021]

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

Considerations for best practices in studies of fiber or other dietary components and the intestinal microbiome. [2023]

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

Exploring changes in the human gut microbiota and microbial-derived metabolites in response to diets enriched in simple, refined, or unrefined carbohydrate-containing foods: a post hoc analysis of a randomized clinical trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effects of OsomeFood Clean Label plant-based meals on the gut microbiome. [2023]