The Effects of Agro-ecological Farming Systems on Human Health

NCT05575258 | Active Not Recruiting

• 1 other identifier: 12519
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

As concerns regarding the effects of agriculture on human and environmental health mount, a growing number of farmers are seeking ways to improve health from the ground up. A promising way by which a growing number of farmers are seeking to improve environmental health is by using agro-ecological practices (i.e., farming more closely in harmony with natural systems), which include practices such as multi-cropping, ley rotations, and/or integrated crop-livestock systems. Despite potential ecological benefits, there is a lack of critical knowledge if consuming foods from agro-ecological systems impacts biomarkers of human health, including inflammatory and metabolomics profiles. The purpose of this project is to test the hypothesis that consuming foods produced using agro-ecological practices improves biomarkers of consumer health compared to consuming similar foods from conventional (monoculture) agriculture. All diets will be matched one-to-one in terms of macronutrients and food sources.

Conditions

Inflammatory Response

Keywords

Human Nutrition; Agro-ecology; Metabolomics; Human Health; Gut Microbiome; Agriculture

Outcome Measures

Primary Outcomes (4)

• Inflammatory cytokine biomarker (IL-6 and TNF-alpha) concentrations in plasma samples

  Inflammatory biomarker concentrations of IL-6 and TNF-alpha (pg/ml) will be measured using ELISA kits at the Center for Human Nutrition Studies at Utah State University. Blood samples will be obtained via phlebotomy at day 44 (post-diet) for each intervention, centrifuged immediately and stored at -80ºC until analyses are performed.

  Day 44 (post)

• Inflammatory cytokine biomarker (C-reactive protein) concentrations in plasma samples

  Inflammatory biomarker concentrations of C-reactive protein (CRP; ng/ml) will be measured using ELISA kits at the Center for Human Nutrition Studies at Utah State University. Blood samples will be obtained via phlebotomy on day 44 (post-diet) for each intervention, centrifuged immediately and stored at -80ºC until analyses are performed.

  Day 44 (post)

• Relative abundance of metabolites in plasma samples using triple quad LC/MS-MS

  Relative abundance (arbitrary units) of plasma metabolites after each diet will be measured using high-performance liquid chromatography tandem mass-spectrometry (LC/MS-MS). This analysis allows the simultaneous high-resolution measurement of a broad range of metabolites and will give insight into how food-derived metabolites from the two different diets impact metabolic pathways of human health. Blood samples will be obtained via phlebotomy on day 44 (post-diet) for each intervention, centrifuged immediately and stored at -80ºC until analyses are performed. Multivariate statistical analysis and Partial least squares Discriminant Analysis will be used to identify features change from pre to post on each diet.

  Day 44 (post)

• Composition of gut microbiota bacteria using 16s rRNA sequencing

  First of the day stool samples will be collected on day 44 (post-diet) for each intervention using DNA Genotek OMR-200 collection kits and stored at -80ºC until analyses are performed. DNA will be extracted from stool samples using a QIAamp Fast DNA Stool Mini Kit following manufacturer's instructions and analyzed for taxonomic assignment using 16s rRNA sequencing. Reported outcomes include individual bacteria and Shannon Index Values.

  Day 44 (post)

Secondary Outcomes (4)

• Pittsburgh Sleep Quality Index (PSQI) scores

  Day 44 (post)

• The Perceived Stress Scale (PSS) scores

  Day 44 (post)

• Profile of Mood States (POMS) scores

  Day 44 (post)

• Short Form Healthy Survey (SF-36) scores

  Day 44 (post)

Study Arms (2)

Sequence 1: Agro (Green) - Conventional (Yellow)

ACTIVE COMPARATOR

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

Other: 44-Day Diet Conventionally Sourced - YELLOW Diet; Other: 44-Day Diet Agro-Ecologically Sourced - GREEN Diet

Sequence 2: Conventional (Yellow) - Agro (Green)

ACTIVE COMPARATOR

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

Other: 44-Day Diet Conventionally Sourced - YELLOW Diet; Other: 44-Day Diet Agro-Ecologically Sourced - GREEN Diet

Interventions

44-Day Diet Conventionally Sourced - YELLOW Diet OTHER

Food for the conventional diet will be sourced from local grocery stores (non-organic produce) around Logan, UT, USA.

Sequence 1: Agro (Green) - Conventional (Yellow); Sequence 2: Conventional (Yellow) - Agro (Green)

44-Day Diet Agro-Ecologically Sourced - GREEN Diet OTHER

Food for the agro-ecological diet will be sourced predominantly from the Greenacres farm (Cincinnati, OH, USA) and a limited number of other retailers that sell select foods from agro-ecological producers (Seal the Seasons, General Mills, Pecan Shop, Sol Simple).

Sequence 1: Agro (Green) - Conventional (Yellow); Sequence 2: Conventional (Yellow) - Agro (Green)

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥35 and ≤60 years
• BMI ≥25 and ≤35kg/m2
• Weight stable in last 3 months (loss or gain \<4%)
• Hemoglobin A1C (HbA1C ≤6.4%)
• Fasting plasma glucose concentration \<126mg/dl
• For the safety of the participant and proper consent of the procedures, subjects must be able to speak and understand English to participate in this study
• Stable medication/supplement use for 3 months prior to study

You may not qualify if:

• Use of medications that are known to affect the study outcome measures (e.g., NSAIDs, corticosteroids) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for this study
• Strict dietary patterns (e.g., vegan, keto)
• Consuming \>14 alcoholic drinks per week
• Use of cigarettes (or other tobacco products) in last 3 months
• Engaged in high level of competitive exercise (e.g., iron man, marathons, powerlifting)
• Diagnoses of active malignancy, congestive heart failure, diabetes mellitus or chronic obstructive pulmonary disease
• Any inflammatory diseases(e.g., autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory. bowel disease, arthritis)
• Use of antibiotics in last 60 days
• Pregnant or planning to become pregnant in the next 5 months
• Lactating women
• 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
• Participants that are pregnant or planning on becoming pregnant in the next 5 months are excluded. The justification is the documented alterations in metabolism that occur during pregnancy, which would impact our metabolomics analysis in this study.

Sponsors & Collaborators

• Utah State University: lead
• GreenAcres Foundation: collaborator

Study Sites (1)

Center for Human Nutrition Studies

Logan, Utah, 84322, United States

Location

Related Publications (7)

• Kronberg SL, Provenza FD, van Vliet S, Young SN. Review: Closing nutrient cycles for animal production - Current and future agroecological and socio-economic issues. Animal. 2021 Dec;15 Suppl 1:100285. doi: 10.1016/j.animal.2021.100285. Epub 2021 Jul 24.

  PMID: 34312093 BACKGROUND

• Wezel, A.et al.Agroecological practices for sustainable agriculture. A review. Agronomy for Sustainable Development34, 1-20, doi:10.1007/s13593-013-0180-7 (2014).

  BACKGROUND

• Albizua, A., Williams, A., Hedlund, K. & Pascual, U. Crop rotations including ley and manure can promote ecosystem services in conventional farming systems. Applied Soil Ecology95, 54-61, doi:https://doi.org/10.1016/j.apsoil.2015.06.003(2015).

  BACKGROUND

• McDaniel MD, Tiemann LK, Grandy AS. Does agricultural crop diversity enhance soil microbial biomass and organic matter dynamics? A meta-analysis. Ecol Appl. 2014 Apr;24(3):560-70. doi: 10.1890/13-0616.1.

  PMID: 24834741 BACKGROUND

• Lain KY, Catalano PM. Metabolic changes in pregnancy. Clin Obstet Gynecol. 2007 Dec;50(4):938-48. doi: 10.1097/GRF.0b013e31815a5494.

  PMID: 17982337 BACKGROUND

• Galie S, Garcia-Gavilan J, Papandreou C, Camacho-Barcia L, Arcelin P, Palau-Galindo A, Rabassa A, Bullo M. Effects of Mediterranean Diet on plasma metabolites and their relationship with insulin resistance and gut microbiota composition in a crossover randomized clinical trial. Clin Nutr. 2021 Jun;40(6):3798-3806. doi: 10.1016/j.clnu.2021.04.028. Epub 2021 Apr 27.

  PMID: 34130026 BACKGROUND

• Meslier V, Laiola M, Roager HM, De Filippis F, Roume H, Quinquis B, Giacco R, Mennella I, Ferracane R, Pons N, Pasolli E, Rivellese A, Dragsted LO, Vitaglione P, Ehrlich SD, Ercolini D. Mediterranean diet intervention in overweight and obese subjects lowers plasma cholesterol and causes changes in the gut microbiome and metabolome independently of energy intake. Gut. 2020 Jul;69(7):1258-1268. doi: 10.1136/gutjnl-2019-320438. Epub 2020 Feb 19.

  PMID: 32075887 BACKGROUND

Related Links

• Google Scholar - Stephan van Vliet
• Center for Human Nutrition Studies - USU

Study Officials

• Stephan van Vliet

  Utah State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to the type of diet (Agroecological or Conventional) they are consuming.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This work will utilize a randomized cross-over design to compare an agroecological vs conventional sourced diet, and determine their effects on inflammation and cardio metabolic health signatures in middle-aged adults (35-60 y old). Diets will be isocaloric and matched for macronutrient content, and consumed for 44 days each with a 14-day washout (habitual diet) period in between. Blood, urine, and stool samples will be obtained at baseline and after the dietary interventions, in addition to data about physical activity and questionnaires regarding quality of life. Participants will be asked to complete four testing visits throughout their participation in the study (pre and post visits for each of the diets, which are 44 days each). Participants will be blinded to the diet they are consuming.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: October 12, 2022
• Study Start: August 1, 2022
• Primary Completion: December 15, 2023
• Study Completion: March 15, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: After analysis and publication are complete.

Locations

US (1)