65 Participants Needed

Diet Intervention for Human Microbiome Health

LW
Overseen ByLisa Whisenhunt
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska Lincoln
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.13567

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.12358

Who Is on the Research Team?

JI

Jacques Izard, PhD

Principal Investigator

Univeristy of Nebraska-Lincoln

Are You a Good Fit for This Trial?

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

Only individuals able to provide a US address will be included
Willing to sign consent and have samples collected
Participants must be willing to use an electronic food diary and consume study provided foods

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.
See 9 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Food providedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska Lincoln

Lead Sponsor

Trials
40
Recruited
13,200+

Published Research Related to This Trial

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.
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]

Citations

A Guide to Diet-Microbiome Study Design. [2020]
Consumption of Two Healthy Dietary Patterns Restored Microbiota Dysbiosis in Obese Patients with Metabolic Dysfunction. [2018]
Microbiome Responses to an Uncontrolled Short-Term Diet Intervention in the Frame of the Citizen Science Project. [2022]
Daily Sampling Reveals Personalized Diet-Microbiome Associations in Humans. [2020]
Integrating Dietary Data into Microbiome Studies: A Step Forward for Nutri-Metaomics. [2021]
Considerations for best practices in studies of fiber or other dietary components and the intestinal microbiome. [2023]
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]
Effects of OsomeFood Clean Label plant-based meals on the gut microbiome. [2023]
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