Agro-Ecological vs Conventional Diet for Inflammation

(AGROHEALTH Trial)

Overseen By Jennifer Cloward, RD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Utah State University

Must not be taking: NSAIDs, Corticosteroids, Anticoagulants, Antibiotics

Disqualifiers: Diabetes, Inflammatory diseases, Active malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the health effects of eating foods from eco-friendly farms versus regular farms in middle-aged adults. Researchers will look at changes in inflammation and metabolism by analyzing blood, urine, and stool samples. The goal is to see if the eco-friendly diet offers better health benefits.

Who Is on the Research Team?

Stephan van Vliet

Principal Investigator

Utah State University

Are You a Good Fit for This Trial?

This trial is for adults aged 35-60 with a BMI between 25 and 35, stable weight and medication use, non-diabetic blood glucose levels, not pregnant or planning to be, moderate alcohol consumption, non-smokers. Excludes those with inflammatory diseases, on certain medications like NSAIDs or steroids, engaged in high-level exercise or following strict diets.

Inclusion Criteria

I am between 35 and 60 years old.

Hemoglobin A1C (HbA1C ≤6.4%)

Fasting plasma glucose concentration <126mg/dl

Exclusion Criteria

I have not taken antibiotics in the last 60 days.

Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits

Strict dietary patterns (e.g., vegan, keto)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention 1

Participants consume either the agroecological or conventional diet for 44 days

44 days

Twice weekly food pick-up visits

Washout Period

Participants return to their habitual diet for 14 days to clear effects of the first diet

14 days

Dietary Intervention 2

Participants switch to the alternate diet (agroecological or conventional) for another 44 days

44 days

Twice weekly food pick-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Agro-ecological Farming Systems

Trial Overview The study compares the health effects of two diets over a period of 44 days: one diet uses conventionally sourced foods (YELLOW Diet), while the other uses foods from agro-ecological farming (GREEN Diet). Both diets are matched for macronutrients and food sources to assess their impact on inflammation and metabolic health markers.

How Is the Trial Designed?

Group I: Sequence 2: Conventional (Yellow) - Agro (Green) Active Control 2 Interventions

First, the conventional sourced diet will be consumed. Secondly, the agro-ecological sourced diet will be consumed.

Group II: Sequence 1: Agro (Green) - Conventional (Yellow) Active Control 2 Interventions

First, the agro-ecological sourced diet will be consumed. Secondly, the conventional sourced diet will be consumed.

Who Is Running the Clinical Trial?

Utah State University

Lead Sponsor

Trials

48

Recruited

5,200+

GreenAcres Foundation

Collaborator

Trials

1

Recruited

30+