The Effect of Soil Biodiversity on Human Gut Microbiome: a Process Pilot Study (The HUMANITAS Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Feasibility of logistics of the study protocol: Deliveries
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18 to 70 years
- •Written informed consent
- •Inhabitant of Leiden
Exclusion Criteria
- •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
- •Use of possible drugs interfering microbiota or recent (< 3 months) changes in dosages
- •A psychiatric, addictive or any other disorder that compromises the participants ability to understand the study content and to give written informed consent for participation in the study
Outcomes
Primary Outcomes
Feasibility of logistics of the study protocol: Deliveries
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.
Feasibility of logistics of the study protocol: Preparation of the intervention product
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.
Feasibility of logistics of the study protocol: Recruitment rate
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.
Tracing back life microorganisms from the smoothie in stool samples
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
Secondary Outcomes
- Sample completeness(From start of treatment to the end of treatment at 4 weeks)
- Participant compliance to the study protocol(From start enrolment until the end of treatment at the end of 4 weeks)
- Shifts in gut microbiome composition(Baseline, Day 8, Day 21, and Day 29)
- Asses willingness of participants to create their own intervention product(From start treatment to end of treatment at 4 weeks)
- Differences in phytonutrient levels in serum(Baseline, Day 8, Day 21, and Day 29)
Investigators
Pieter Maljaars
gastroenterologist
Leiden University Medical Center