Inflammatory ResponseAGROHEALTHNCT05575258
The Effects of Agro-ecological Farming Systems on Human Health
A study testing 44-Day Diet Conventionally Sourced - YELLOW Diet and 44-Day Diet Agro-Ecologically Sourced - GREEN Diet in people with Inflammatory Response, run by Utah State University at 1 site in United States.
Trial 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.… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- 44-Day Diet Conventionally Sourced - YELLOW Diet and 44-Day Diet Agro-Ecologically Sourced - GREEN Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Nutrition Studies
Logan, Utah, 84322
About this study
Official title: The Effects of Agro-ecological Farming Systems on Human Health -- A Randomized Controlled Trial of Agro-ecologically vs Conventionally Produced Foods on Human Health Biomarkers
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.
Read the detailed description
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 before and after the dietary interventions, in addition to data about physical activity and questionnaires regarding quality of life.
STUDY OBJECTIVES
- To determine the effects on plasma inflammatory markers (IL-6, TNF-α, C-reactive protein) in response to each intervention.
- To determine effects on urinary and plasma metabolites (vitamin and mineral derivatives, polyphenols, amino acids, glucose metabolites etc.) to provide insight into metabolic health pathways in response to each intervention.
- To determine effects on gut microbiota communities (alpha and beta diversity, and short-chain fatty acid producing bacteria) in response to each intervention.
INTERVENTION
After completing all baseline testing, participants will be randomized to one of the two starting diets (agroecological or conventional, for 44 days with a 14 day washout period until they start their second diet (agroecological or conventional depending on the starting diet). In accordance with established protocols, a research dietitian will provide weight-maintenance diets based on each individual's daily energy requirement (Harris-Benedict equation). All foods that participants consume during those 44 days will be provided by the Metabolic Kitchen at NDFS, and dietitian-led group classes and handouts with food preparation instructions will be provided to the participants to ensure compliance. The diets will be provided as 4-day rotating menus and participants will be asked to pick-up food twice weekly at the NDFS building. This will allow the research time to interact face-to-face with the participant, address any issues, and further ensure compliance. All subjects assigned to the same diet will receive identical meals and snacks, but portion sizes will be determined based on the previously mentioned daily energy requirement. Food for the agroecological diet will be sourced predominantly from the Greenacres farm (Cincinnati, OH) and/or other producers that use documented agro-ecological principles (e.g., Regenerative Organic Certified). Food for the conventional diet will be sourced from local grocery stores in Logan, UT (non-organic produce). All foods will be stored in food-grade fridges and freezers in the CHNS Metabolic Kitchen and food boxes will be prepared weekly by staff.
Examples of Meals
Breakfast Whole milk, eggs, oatmeal, and blueberries
Snack Rice cakes
Lunch Ground beef, tomato salad and cherries
Snack Apple with nut butter
Dinner Grilled chicken with rice and steamed broccoli
- Conditions
- Inflammatory Response
- Being tested
- 44-Day Diet Conventionally Sourced - YELLOW Diet, 44-Day Diet Agro-Ecologically Sourced - GREEN Diet
- Keywords
- Human Nutrition, Agro-ecology, Metabolomics, Human Health, Gut Microbiome, Agriculture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
44-Day Diet Conventionally Sourced - YELLOW DietOther
Food for the conventional diet will be sourced from local grocery stores (non-organic produce) around Logan, UT, USA.
44-Day Diet Agro-Ecologically Sourced - GREEN DietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 44-Day Diet Conventionally Sourced - YELLOW Diet; Other: 44-Day Diet Agro-Ecologically Sourced - GREEN Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 44 (post)
Secondary outcomes (4)
Pittsburgh Sleep Quality Index (PSQI) scores
The PSQI will be used to determine sleep quality. Assessments will be performed on day 44 (post-diet) for each intervention. PSQI yields a total score ranging from 0 to 21 with a higher total score (referred to as global score) indicating worse sleep quality.
Measured: Day 44 (post)
The Perceived Stress Scale (PSS) scores
PSS evaluates how unpredictable, uncontrollable, and overloaded participants judge their lives. Assessments will be performed on day 44 (post-diet) for each intervention. PSS scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Day 44 (post)
Profile of Mood States (POMS) scores
The Profile of Mood States (POMS) 30-item version will determine mood changes using the following domains: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia and Confusion-Bewilderment. Assessments will be performed on day 44 (post-diet) for each intervention. This will give a value between -24 and 177, with lower scores indicative of people with more stable mood profiles.
Measured: Day 44 (post)
Short Form Healthy Survey (SF-36) scores
The SF-36 will be used to assess quality of life using physical (functioning, role-physical, pain, general health) and mental domains (vitality, social functioning, role-emotional, and mental health). Assessments will be performed on day 44 (post-diet) for each intervention. The SF-36 scores on a range from 0-100 with higher scores indicating better physical and mental health.
Measured: Day 44 (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Aug 2022
- Primary completion15 Dec 2023
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Collaborators
- GreenAcres Foundation
- Responsible party
- Principal investigator, Stephanvanvliet, Utah State University
- Investigators
- Stephan van Vliet, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575258
- Sponsor's protocol ID
- 12519
- Acronym
- AGROHEALTH
- Status last verified
- Jul 2024
- First submitted
- 31 May 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Decoded metabolomics data will be posted in public repositories (Metabolomics Workbench) Decoded inflammatory biomarker, gut microbiome, and bloodwork data will be added as supplemental information to the publication.
Publications
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.
PubMed 34312093Wezel, A.et al.Agroecological practices for sustainable agriculture. A review. Agronomy for Sustainable Development34, 1-20, doi:10.1007/s13593-013-0180-7 (2014).
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).
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.
PubMed 24834741Lain KY, Catalano PM. Metabolic changes in pregnancy. Clin Obstet Gynecol. 2007 Dec;50(4):938-48. doi: 10.1097/GRF.0b013e31815a5494.
PubMed 17982337Galie 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.
PubMed 34130026Meslier 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.
PubMed 32075887
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Agro-ecological Farming Systems on Human Health -- A Randomized Controlled Trial of Agro-ecologically vs Conventionally Produced Foods on Human Health Biomarkers
- ClinicalTrials.gov ID
- NCT05575258
- Acronym / sponsor ID
- AGROHEALTH / 12519
- Conditions
- Inflammatory Response
- Keywords
- Human Nutrition, Agro-ecology, Metabolomics, Human Health, Gut Microbiome, Agriculture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Collaborators
- GreenAcres Foundation
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 before and after the dietary interventions, in addition to data about physical activity and questionnaires regarding quality of life.
STUDY OBJECTIVES
- To determine the effects on plasma inflammatory markers (IL-6, TNF-α, C-reactive protein) in response to each intervention.
- To determine effects on urinary and plasma metabolites (vitamin and mineral derivatives, polyphenols, amino acids, glucose metabolites etc.) to provide insight into metabolic health pathways in response to each intervention.
- To determine effects on gut microbiota communities (alpha and beta diversity, and short-chain fatty acid producing bacteria) in response to each intervention.
INTERVENTION
After completing all baseline testing, participants will be randomized to one of the two starting diets (agroecological or conventional, for 44 days with a 14 day washout period until they start their second diet (agroecological or conventional depending on the starting diet). In accordance with established protocols, a research dietitian will provide weight-maintenance diets based on each individual's daily energy requirement (Harris-Benedict equation). All foods that participants consume during those 44 days will be provided by the Metabolic Kitchen at NDFS, and dietitian-led group classes and handouts with food preparation instructions will be provided to the participants to ensure compliance. The diets will be provided as 4-day rotating menus and participants will be asked to pick-up food twice weekly at the NDFS building. This will allow the research time to interact face-to-face with the participant, address any issues, and further ensure compliance. All subjects assigned to the same diet will receive identical meals and snacks, but portion sizes will be determined based on the previously mentioned daily energy requirement. Food for the agroecological diet will be sourced predominantly from the Greenacres farm (Cincinnati, OH) and/or other producers that use documented agro-ecological principles (e.g., Regenerative Organic Certified). Food for the conventional diet will be sourced from local grocery stores in Logan, UT (non-organic produce). All foods will be stored in food-grade fridges and freezers in the CHNS Metabolic Kitchen and food boxes will be prepared weekly by staff.
Examples of Meals
Breakfast Whole milk, eggs, oatmeal, and blueberries
Snack Rice cakes
Lunch Ground beef, tomato salad and cherries
Snack Apple with nut butter
Dinner Grilled chicken with rice and steamed broccoli
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Agro (Green) - Conventional (Yellow) | Active comparator | Other: 44-Day Diet Conventionally Sourced - YELLOW Diet, Other: 44-Day Diet Agro-Ecologically Sourced - GREEN DietFirst, the agro-ecological sourced diet will be consumed. Secondly, the conventional sourced diet will be consumed. |
| Sequence 2: Conventional (Yellow) - Agro (Green) | Active comparator | Other: 44-Day Diet Conventionally Sourced - YELLOW Diet, Other: 44-Day Diet Agro-Ecologically Sourced - GREEN DietFirst, the conventional sourced diet will be consumed. Secondly, the agro-ecological sourced diet will be consumed. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 44-Day Diet Conventionally Sourced - YELLOW DietFood for the conventional diet will be sourced from local grocery stores (non-organic produce) around Logan, UT, USA. | Other | Sequence 1: Agro (Green) - Conventional (Yellow), Sequence 2: Conventional (Yellow) - Agro (Green) |
| 44-Day Diet Agro-Ecologically Sourced - GREEN DietFood 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). | Other | Sequence 1: Agro (Green) - Conventional (Yellow), Sequence 2: Conventional (Yellow) - Agro (Green) |
Primary outcome
Inflammatory cytokine biomarker (IL-6 and TNF-alpha) concentrations in plasma samples
Time frame: Day 44 (post)
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.
Inflammatory cytokine biomarker (C-reactive protein) concentrations in plasma samples
Time frame: Day 44 (post)
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.
Relative abundance of metabolites in plasma samples using triple quad LC/MS-MS
Time frame: Day 44 (post)
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.
Composition of gut microbiota bacteria using 16s rRNA sequencing
Time frame: Day 44 (post)
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.
4 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI) scores
Time frame: Day 44 (post)
The Perceived Stress Scale (PSS) scores
Time frame: Day 44 (post)
Profile of Mood States (POMS) scores
Time frame: Day 44 (post)
Short Form Healthy Survey (SF-36) scores
Time frame: Day 44 (post)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 34312093Kronberg 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.
- BackgroundWezel, A.et al.Agroecological practices for sustainable agriculture. A review. Agronomy for Sustainable Development34, 1-20, doi:10.1007/s13593-013-0180-7 (2014).
- BackgroundAlbizua, 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: PubMed 24834741McDaniel 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.
- Background: PubMed 17982337Lain KY, Catalano PM. Metabolic changes in pregnancy. Clin Obstet Gynecol. 2007 Dec;50(4):938-48. doi: 10.1097/GRF.0b013e31815a5494.
- Background: PubMed 34130026Galie 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.
- Background: PubMed 32075887Meslier 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.
- Google Scholar - Stephan van VlietLink provided by the sponsor.
- Center for Human Nutrition Studies - USULink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Decoded metabolomics data will be posted in public repositories (Metabolomics Workbench) Decoded inflammatory biomarker, gut microbiome, and bloodwork data will be added as supplemental information to the publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan van Vliet principal investigator
Utah State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 44-Day Diet Conventionally Sourced - YELLOW Diet and 44-Day Diet Agro-Ecologically Sourced - GREEN Diet in people with Inflammatory Response, run by Utah State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory cytokine biomarker (IL-6 and TNF-alpha) concentrations in plasma samples (time frame: Day 44 (post)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575258, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.