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Agro-Ecological vs Conventional Diet for Inflammation (AGROHEALTH Trial)
N/A
Waitlist Available
Led By Stephan van Vliet
Research Sponsored by Utah State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 44 (post)
Awards & highlights
No Placebo-Only Group
Summary
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 the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves dietary changes rather than medication or medical procedures, side effects may include digestive discomfort as participants adjust to new eating patterns. However specific side effects will depend on individual reactions to different food sources.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 44 (post)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 44 (post)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composition of gut microbiota bacteria using 16s rRNA sequencing
C-reactive protein
Inflammatory cytokine biomarker (IL-6 and TNF-alpha) concentrations in plasma samples
+1 moreSecondary study objectives
Pittsburgh Sleep Quality Index (PSQI) scores
Profile of Mood States (POMS) scores
Short Form Healthy Survey (SF-36) scores
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Sequence 2: Conventional (Yellow) - Agro (Green)Active Control2 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 Control2 Interventions
First, the agro-ecological sourced diet will be consumed.
Secondly, the conventional sourced diet will be consumed.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for inflammation include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and biologics such as TNF-alpha inhibitors. NSAIDs work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), reducing the production of prostaglandins that cause inflammation and pain.
Corticosteroids suppress the immune system by decreasing the production of inflammatory chemicals and reducing the activity of immune cells. TNF-alpha inhibitors block the action of tumor necrosis factor-alpha, a cytokine involved in systemic inflammation.
For inflammation patients, understanding these mechanisms is crucial as it highlights the importance of targeting specific pathways to reduce inflammation effectively. Additionally, dietary interventions, such as consuming foods from agro-ecological systems, may offer complementary benefits by potentially improving inflammatory biomarkers, thus providing a holistic approach to managing inflammation.
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Who is running the clinical trial?
Utah State UniversityLead Sponsor
45 Previous Clinical Trials
4,733 Total Patients Enrolled
5 Trials studying Inflammation
158 Patients Enrolled for Inflammation
GreenAcres FoundationUNKNOWN
Stephan van VlietPrincipal InvestigatorUtah State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken antibiotics in the last 60 days.I am between 35 and 60 years old.My medications or supplements have been the same for the last 3 months.I have an inflammatory disease like arthritis or hepatitis.I have been diagnosed with cancer, heart failure, diabetes, or COPD.I am not taking any medication that could interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence 2: Conventional (Yellow) - Agro (Green)
- Group 2: Sequence 1: Agro (Green) - Conventional (Yellow)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.