Obesity PreventionMITANCT07165145
Effect of Agricultural Practices on Crops, Gut Microbiome, and Human Health
A study testing Organic Fruits and Vegetables and Conventional Fruits and Vegetables in people with Obesity Prevention and Microbiome Analysis, run by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) at 1 site in Netherlands.
Trial summary
The human gut microbiome plays a regulatory role in host health, and is involved in metabolic, immune, and neurological processes. Diet shapes the gut microbiome; by providing essential nutrients, which sustain the existing microorganisms and by introducing foodborne microbes that modulate its composition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention, Microbiome Analysis
- What is being tested?
- Organic Fruits and Vegetables and Conventional Fruits and Vegetables
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jun 2025to 21 Nov 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 22 Healthy Volunteers : healthy Caucasian adults with a BMI < 25 kg/m^2 will be recruited with no medical conditions.
- 22 Metabolically Impaired Participants: Caucasian adults with a BMI ranging from 28 kg/m^2 to 40 kg/m^2 with three components of Metabolic Syndrome, drug-naïve:
- Elevated waist circumference (WC): with men having WC > 102 cm (40 inches) and women having a WC > 88 cm (35 inches).
- High Fasting Plasma Glucose (FPG): a fasting plasma glucose level 110 mg/dL (6.1 mmol/L)
- High Fasting Plasma Insulin (FPI): A fasting insulin level ≥25 μU/mL (or >16.7 pmol/L)
- HOMA-IR score of ≥2.5
Who cannot join
- Use of antibiotic in the past 3 months or currently taking them
- Past/ Currently following a vegan, strictly organic or vegetarian diet.
- History of severe food allergies or intolerances that would render it unsafe for them to consume any of the fruits and vegetables provided. Exclusion will be determined on a case-by-case basis by the investigator.
- Inability or unwillingness to collect stools.
- Presence of overt type 1 diabetes mellitus (T1DM) and/or type 2 diabetes.
- Use of medications for type 2 diabetes: metformin, statin, proton pump inhibitors (PPI), H2 blockers, pioglitazone, active GLP-1 receptor agonists (e.g., exenatide, liraglutide).
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- Prior or planned bariatric surgery, history of cholecystectomy.
- History of cardiovascular disease, having a severe disease of the digestive tract, such as celiac disease, Crohn's disease, active ulcerative colitis.
- Surgery scheduled for the trial duration period.
- Pregnant or nursing women.
- Smoking or illicit drug use. Use of >5 units of alcohol daily on average.
- History of neurological/neurodegenerative disorders.
- Participation in another concomitant clinical trial.
- Not residing in the Netherlands during study period (Sept-Nov 2025)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, locatie AMC
Amsterdam, Amsterdam, 1105 AZ
About this study
Official title: MicroHealth Project: Human Trial A A Randomized Comparative Trial to Examine the Impact of Organically vs Conventionally Grown Crops on the Human Gut Microbiome and Health
The human gut microbiome plays a regulatory role in host health, and is involved in metabolic, immune, and neurological processes. Diet shapes the gut microbiome; by providing essential nutrients, which sustain the existing microorganisms and by introducing foodborne microbes that modulate its composition. Notably, the impact of microbes from fruit and vegetables on the gut microbiome is relatively unexplored. Differences in agricultural practices, organic vs conventional strategies, can lead to variations in nutritional content and associated microbial communities in and on crops, underscoring the potential for variations in cultivated crops to influence the human gut microbiome's composition and function. This study aims to explore how crop cultivation practices affect the composition and function of the human gut microbiome, ultimately influencing overall health.
Read the detailed description
Objective:
The primary objective of this study is to investigate the effect of differentially cultivated crops (organic versus conventional) on cardiometabolic health outcomes, as reflected by measurements of glucose metabolism and its relation to the gut microbiome composition and function.
The secondary objectives are to assess the effect of differently grown crops on gut microbiome composition and function, plasma and fecal short-chain fatty acid levels, including quantification of pesticide residues and other contaminants in blood and faeces. Additionally, changes will be evaluated in metabolomics of the blood and breath volatile organic compounds (QuinTron), as well as alterations in weight, body composition.
Double-blind randomized dietary intervention study, parallel design. A total of 40 male and female volunteers will be recruited for this study, aged 18-45 years.
20 will have a normal BMI of 19-25 with no current medical conditions, while the remaining 20 will have a BMI of 28-40 with three components of Metabolic Syndrome, drug-naïve.
Participants will be assigned to one of two groups for 4 weeks of dietary intervention. One group will receive produce from conventional agriculture, while the other receives produce from organic agriculture, with a specific focus on differently grown fruits and vegetables.
Both groups will receive:
- A weekly full meal recipe kit (6 days/week) with ingredients and instructions on preparation
- A separate weekly box containing additional fruits and vegetables (6 days/week)
- Conditions
- Obesity Prevention, Microbiome Analysis
- Being tested
- Organic Fruits and Vegetables, Conventional Fruits and Vegetables
- Keywords
- Microbiome, Agricultural Strategies, Fruits and Vegetables, Diet, Organic and Conventional, Biological, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic Fruits and VegetablesDietary supplement
Dietary Intervention
Conventional Fruits and VegetablesDietary supplement
Dietary Intervention
| Study group | Role | What they receive |
|---|---|---|
| A) 11 MetSyn participants | Active comparator | Organic Fruits and Vegetables Receives: Dietary Supplement: Organic Fruits and Vegetables |
| B) 11 MetSyn participants | Active comparator | Conventional Fruits and Vegetables Receives: Dietary Supplement: Conventional Fruits and Vegetables |
| C) 11 Healthy participants | Active comparator | Organic Fruits and Vegetables Receives: Dietary Supplement: Organic Fruits and Vegetables |
| D) Healthy participants | Active comparator | Conventional Fruits and Vegetables Receives: Dietary Supplement: Conventional Fruits and Vegetables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
The primary objective of this study is to investigate the effect of deferentially cultivated crops (organic versus conventional) on glucose levels. Measured by the difference in time in range between the groups between baseline, end-of-diet intervention
Measured: At Baseline, week 4 (End-of-intervention)
Secondary outcomes (13)
Continuous glucose monitoring
Changes in glycemic variability, time above range, time below range and hypoglycemic episodes
Measured: Between Baseline (week-1) and End-of-intervention (week4)
Gut microbiome
Gut microbiome analysis will include qualitative and quantitative assessment via 16S and whole-genome sequencing, differential abundance testing with DESeq2, strain-level tracking using InStrain, and PERMANOVA to evaluate temporal effects
Measured: Every week from baseline (week -1) to follow-up (week 6)
Body Composition
Body Impedance Analysis: Free fat mass (kg; %). Fat mass (kg; %). Rest Metabolic Rate (kcal/day).
Measured: Baseline, End-of-intervention (week 4), Follow-up (week 6)
Anthropometric measurements
Weight will be measured in kilograms (kg). Height will be measured in meters (m). These two measurements will also be combined to calculate Body Mass Index (BMI), defined as weight in kilograms divided by height in meters squared (kg/m²)
Measured: Baseline, week 4 and follow-up (week 6)
Dietary Intake
Recorded of 3 days with "Eetmeter"
Measured: Baseline (week -1), End-of-Intervention (week 4), follow-up (week 6)
HbA1c
Millimoles of HbA1c per mole of hemoglobin (mmol/mol)
Measured: Baseline, End-of-Intervention (week 4), follow-up (week 6)
HOMA-IR
(Fasting Insulin * Fasting Glucose) / Constant
Measured: Baseline, End-of-Intervention (week 4), follow-up (week 6)
Leukocyte (differentation)
×10 9 /L
Measured: Between Baseline and End-of-intervention (week4), follow-up (week 6)
CRP
C-reactive protein (mg/L)
Measured: Between Baseline and End-of-intervention (week4), follow-up (week 6)
Physical Activity Questionnaire
Physical Activity Questionnaire (SQUASH - Short Questionnaire to Assess Health-enhancing Physical Activity): Assesses weekly physical activity levels across commuting, household, leisure, and work/school activities. Scores are reported in MET-hours per week, with higher scores indicating greater physical activity. Range of activity levels: Low: <10 MET-hours/week, Moderate: 10-29 MET-hours/week, High: ≥30 MET-hours/week.
Measured: Between Baseline (week-1), End-of-intervention (week4) and Follow-up (week 6)
Breath Gas H₂
Breath test performed with the QuinTron analyzer, measuring hydrogen (H₂) concentration in parts per million (ppm) as an indicator of fermentation.
Measured: Baseline, End-of-Intervention (week 4), follow-up (week 6)
Breath Gas CH₄
Breath test conducted with the QuinTron analyzer to measure methane (CH₄) concentration, expressed in parts per million (ppm), as an indicator of fermentation.
Measured: Baseline, End-of-Intervention (week 4), follow-up (week 6)
Breath Gas CO₂
Breath test conducted with the QuinTron analyzer to measure carbon dioxide (CO₂) concentration, expressed as a percentage (%) as control marker
Measured: Baseline, End-of-Intervention (week 4), follow-up (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start25 Jun 2025
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity PreventionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study design: Double-blind randomized dietary intervention study, parallel design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Nieuwdorp, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Investigators
- Max Nieuwdorp, Dr. Prof., Principal investigator, Dept of Vascular Medicine, Amsterdam UMC - AMCHilde H.J. Herrema, PhD, Principal investigator, Dept of Vascular Medicine, Amsterdam UMC - AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165145
- Sponsor's protocol ID
- NL88508.018.24
- Acronym
- MITA
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroHealth Project: Human Trial A A Randomized Comparative Trial to Examine the Impact of Organically vs Conventionally Grown Crops on the Human Gut Microbiome and Health
- ClinicalTrials.gov ID
- NCT07165145
- Acronym / sponsor ID
- MITA / NL88508.018.24
- Conditions
- Obesity Prevention, Microbiome Analysis
- Keywords
- Microbiome, Agricultural Strategies, Fruits and Vegetables, Diet, Organic and Conventional, Biological, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)University, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 10 Sep 2025 (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.
The human gut microbiome plays a regulatory role in host health, and is involved in metabolic, immune, and neurological processes. Diet shapes the gut microbiome; by providing essential nutrients, which sustain the existing microorganisms and by introducing foodborne microbes that modulate its composition. Notably, the impact of microbes from fruit and vegetables on the gut microbiome is relatively unexplored. Differences in agricultural practices, organic vs conventional strategies, can lead to variations in nutritional content and associated microbial communities in and on crops, underscoring the potential for variations in cultivated crops to influence the human gut microbiome's composition and function. This study aims to explore how crop cultivation practices affect the composition and function of the human gut microbiome, ultimately influencing overall health.
Detailed description
Objective:
The primary objective of this study is to investigate the effect of differentially cultivated crops (organic versus conventional) on cardiometabolic health outcomes, as reflected by measurements of glucose metabolism and its relation to the gut microbiome composition and function.
The secondary objectives are to assess the effect of differently grown crops on gut microbiome composition and function, plasma and fecal short-chain fatty acid levels, including quantification of pesticide residues and other contaminants in blood and faeces. Additionally, changes will be evaluated in metabolomics of the blood and breath volatile organic compounds (QuinTron), as well as alterations in weight, body composition.
Double-blind randomized dietary intervention study, parallel design. A total of 40 male and female volunteers will be recruited for this study, aged 18-45 years.
20 will have a normal BMI of 19-25 with no current medical conditions, while the remaining 20 will have a BMI of 28-40 with three components of Metabolic Syndrome, drug-naïve.
Participants will be assigned to one of two groups for 4 weeks of dietary intervention. One group will receive produce from conventional agriculture, while the other receives produce from organic agriculture, with a specific focus on differently grown fruits and vegetables.
Both groups will receive:
- A weekly full meal recipe kit (6 days/week) with ingredients and instructions on preparation
- A separate weekly box containing additional fruits and vegetables (6 days/week)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Study design: Double-blind randomized dietary intervention study, parallel design.
| Arm | Type | Receives |
|---|---|---|
| A) 11 MetSyn participants | Active comparator | Dietary Supplement: Organic Fruits and VegetablesOrganic Fruits and Vegetables |
| B) 11 MetSyn participants | Active comparator | Dietary Supplement: Conventional Fruits and VegetablesConventional Fruits and Vegetables |
| C) 11 Healthy participants | Active comparator | Dietary Supplement: Organic Fruits and VegetablesOrganic Fruits and Vegetables |
| D) Healthy participants | Active comparator | Dietary Supplement: Conventional Fruits and VegetablesConventional Fruits and Vegetables |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 22 Healthy Volunteers : healthy Caucasian adults with a BMI < 25 kg/m^2 will be recruited with no medical conditions.
- 22 Metabolically Impaired Participants: Caucasian adults with a BMI ranging from 28 kg/m^2 to 40 kg/m^2 with three components of Metabolic Syndrome, drug-naïve:
Key exclusion criteria (14 listed)
- Use of antibiotic in the past 3 months or currently taking them
- Past/ Currently following a vegan, strictly organic or vegetarian diet.
- History of severe food allergies or intolerances that would render it unsafe for them to consume any of the fruits and vegetables provided. Exclusion will be determined on a case-by-case basis by the investigator.
- Inability or unwillingness to collect stools.
- Presence of overt type 1 diabetes mellitus (T1DM) and/or type 2 diabetes.
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 |
|---|---|---|
| Organic Fruits and VegetablesDietary Intervention | Dietary supplement | A) 11 MetSyn participants, C) 11 Healthy participants |
| Conventional Fruits and VegetablesDietary Intervention | Dietary supplement | B) 11 MetSyn participants, D) Healthy participants |
Primary outcome
Time in Range
Time frame: At Baseline, week 4 (End-of-intervention)
The primary objective of this study is to investigate the effect of deferentially cultivated crops (organic versus conventional) on glucose levels. Measured by the difference in time in range between the groups between baseline, end-of-diet intervention
13 secondary outcomes
Continuous glucose monitoring
Time frame: Between Baseline (week-1) and End-of-intervention (week4)
Gut microbiome
Time frame: Every week from baseline (week -1) to follow-up (week 6)
Body Composition
Time frame: Baseline, End-of-intervention (week 4), Follow-up (week 6)
Anthropometric measurements
Time frame: Baseline, week 4 and follow-up (week 6)
Dietary Intake
Time frame: Baseline (week -1), End-of-Intervention (week 4), follow-up (week 6)
HbA1c
Time frame: Baseline, End-of-Intervention (week 4), follow-up (week 6)
HOMA-IR
Time frame: Baseline, End-of-Intervention (week 4), follow-up (week 6)
Leukocyte (differentation)
Time frame: Between Baseline and End-of-intervention (week4), follow-up (week 6)
CRP
Time frame: Between Baseline and End-of-intervention (week4), follow-up (week 6)
Physical Activity Questionnaire
Time frame: Between Baseline (week-1), End-of-intervention (week4) and Follow-up (week 6)
Breath Gas H₂
Time frame: Baseline, End-of-Intervention (week 4), follow-up (week 6)
Breath Gas CH₄
Time frame: Baseline, End-of-Intervention (week 4), follow-up (week 6)
Breath Gas CO₂
Time frame: Baseline, End-of-Intervention (week 4), follow-up (week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Healthy Volunteers
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.
Max Nieuwdorp, Dr. Prof. principal investigator
Dept of Vascular Medicine, Amsterdam UMC - AMC
Hilde H.J. Herrema, PhD principal investigator
Dept of Vascular Medicine, Amsterdam UMC - AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organic Fruits and Vegetables and Conventional Fruits and Vegetables in people with Obesity Prevention and Microbiome Analysis, run by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) at 1 site in Netherlands.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 23 Jun 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time in Range (time frame: At Baseline, week 4 (End-of-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.