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Agro-Ecological vs Conventional Diet for Inflammation (AGROHEALTH Trial)
N/A
Recruiting
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
AGROHEALTH Trial Summary
This trial will investigate if foods from agro-ecological farming systems improve consumer health compared to conventional farming.
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.Check my eligibility
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.See study design
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.
AGROHEALTH Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Pittsburgh Sleep Quality Index (PSQI) scores
Profile of Mood States (POMS) scores
Short Form Healthy Survey (SF-36) scores
+1 moreAGROHEALTH 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.
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Who is running the clinical trial?
Utah State UniversityLead Sponsor
44 Previous Clinical Trials
4,372 Total Patients Enrolled
4 Trials studying Inflammation
122 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open opportunities for participants in this medical investigation?
"As of October 18th, 2022 the clinical trial is actively seeking participants. This research was first advertised on August 1st and has since been updated with new information."
Answered by AI
How many applicants have been approved for participation in this trial?
"Affirmative. Clinicaltrials.gov confirms that this medical research, which was first posted on August 1st 2022, is actively enrolling participants. The study requires approximately 40 volunteers from a single site to partake in the trial."
Answered by AI
What outcome is this clinical trial hoping to achieve?
"This study aims to measure the composition of gut bacteria through 16s rRNA sequencing on Day 44. Secondary objectives will include SF-36 scores (0-100, higher indicating better physical and mental health), POMS scores (-24 to 177, lower indicative of more stable mood) and PSS scores (0-40, high score implies heightened stress)."
Answered by AI
What are the eligibility requirements for participating in this experiment?
"Individuals aged 35 to 60 who are experiencing inflammatory responses can be considered for inclusion in this trial. 40 participants need to be enrolled in total."
Answered by AI
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