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.
Aged 18 to 70 years
Written informed consent
Inhabitant of Leiden
Any documented causes of chronic disease
Suspicion of or present excessive alcohol use defined as >2 units/day (>14/week)
Recent use (<3 months) of antibiotics
Any known food allergy or restriction, or following a vegan/vegetarian diet
Crossover
Low diversity vegetable smoothie
Other interventionVegetable smoothie prepared with crops grown in low-microbial diversity soil
High diversity vegetable smoothie
Other interventionVegetable smoothie prepared with crops grown in high-microbial diversity soil
Feasibility of logistics of the study protocol: Deliveries
The percentage of successful deliveries to the participants in the pre-agreed time window.
Feasibility of logistics of the study protocol: Preparation of the intervention product
Using the Daily diary (Castor questionnaire), successful preparation of the intervention product is assessed.
Feasibility of logistics of the study protocol: Recruitment rate
Number of recruited participants per month until the start of the study.
Tracing back life microorganisms from the smoothie in stool samples
Life bacteria present in the smoothies will be cultured and sequenced to then compare to feces samples of participants
Participant compliance to the study protocol
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.
Shifts in gut microbiome composition
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
Sample completeness
percentage of complete sampling sets
Asses willingness of participants to create their own intervention product
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.
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Leiden University Medical Center
Lead sponsor
Maastricht University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
