Leids Universitair Medisch Centrum
Leiden, South Holland, 2333ZA, Netherlands
Location contact
Jeroen Maljaars, MD, PhD
CONTACT
Jeroen Maljaars, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07742319
There are two objectives for this clinical trial. The first is to test whether, with the current logistics and study setup it is possible to perform the study well and see where there might be bottlenecks we couldn't predict. The second objective is to investigate the relation between the composition of the microorganisms in the soil, the crops that grow in that soil, and the human gut. During the study participants will drink three vegetable smoothies a day, for two periods of one week. The only difference between the two periods is whether the vegetables come from a farm with a low diversity of microorganisms in the soil or a high diversity. Participants will be asked to give blood samples and turn in fecal samples before and after each period.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Leiden, South Holland, 2333ZA, Netherlands
Jeroen Maljaars, MD, PhD
CONTACT
Jeroen Maljaars, MD, PhD
PRINCIPAL_INVESTIGATOR
This randomized, double-blind, crossover pilot study will be used to assess the feasibility of logistics including vegetable delivery and preparation of the intervention product by the participants themselves. Besides feasibility, we will aim to identify live bacteria and fungi present in the intervention product (smoothies) and trace these back in stool samples.
The gut microbiome is also called the "second genome" to which many protective and life-supporting functions have been externalized. It orchestrates the crosstalk between our own cells and environmental metagenome. Diet and food choices can modulate gut microbiome species and functional diversity, but the mechanisms by which this occurs are unclear. The nutritional quality of crops, the crop microbiome and the soil microbiome may therefore all be involved.
Ten participants will be randomized in a cross-over design, with each participant drinking three 150 mL vegetable smoothies per day for two separate intervention weeks (HiDi vs LoDi soil origin, randomized 1 : 1). During the first week, smoothies will be prepared with the vegetables derived from microbiome-enriched soil (HiDi) or microbiome-impoverished soil (LoDi). Vegetables, a blender, and detailed instructions to prepare the smoothies on-site will be delivered to the participant. Each participant is asked to keep a diary (in the form of a daily Castor questionnaire), with special attention to dietary habits and intake. Furthermore, before and after this specified diet week, blood and stool samples will be collected. After a washout period of two weeks, participants will be offered identical meals in a crossover design.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vegetable smoothie prepared with crops grown in low-microbial diversity soil
Vegetable smoothie prepared with crops grown in high-microbial diversity soil
Time frame: From start enrollment to the end of treatment at 4 weeks
The percentage of successful deliveries to the participants in the pre-agreed time window.
Time frame: From the start of the treatment period until the end at 4 weeks
Using the Daily diary (Castor questionnaire), successful preparation of the intervention product is assessed.
Time frame: From the start of recruitment until the start of the study
Number of recruited participants per month until the start of the study.
Time frame: Day 1, Day 7, Day 22, and Day 28
Life bacteria present in the smoothies will be cultured and sequenced to then compare to feces samples of participants
Time frame: From start enrolment until the end of treatment at the end of 4 weeks
Compliance with the protocol will be assessed through the daily lifestyle diary (in the form of a Castor questionnaire). Which will capture the number of consumed smoothies (≥95.2%) and number of consumed smoothies at the correct time window (≥80%). As well whether the duration and time of exercise (≥80%), duration and time of nighttime sleeping period (≥80%), timing and content of main meals (≥80%) between the two periods are comparable. For each of the parameters the compliance threshold is indicated above. Based on these parameters we will get a percentage of participants that were compliant.
Time frame: Baseline, Day 8, Day 21, and Day 29
Metagenomics will be performed on feces samples from participants to get an compositional view of the gut microbiome. Samples will be taken at baseline, Day 8, Day 21, and Day 29
Time frame: From start of treatment to the end of treatment at 4 weeks
percentage of complete sampling sets
Time frame: From start treatment to end of treatment at 4 weeks
Using the Daily diary (Castor questionnaire), the participants are required to fill in their opinion on creating their own intervention product on a daily basis. This is measured on a 10 point scale, with 1 being equal to never wanting to do it again and 10 being equal to enjoying it. There is also an optional open question where participants can justify their answer.
Time frame: Baseline, Day 8, Day 21, and Day 29
After confirmation of significant changes in gut microbiome composition, phytonutrient levels will be measured in serum. Serum will be collected at Baseline, Day 8, Day 21, and Day 29
Contact information is provided by the study sponsor or research team.
Jeroen Maljaars, MD, PhD
CONTACT
Maarten Tushuizen, MD, PhD
CONTACT
Leiden University Medical Center
Other
The Effect of Soil Biodiversity on Human Gut Microbiome: a Process Pilot Study (The HUMANITAS Study)
Acronym: HUMANITAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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