How Differences in the Composition of Microorganisms in the Soil Affect the Microorganisms in the Human Gut, Through the Vegetables That Grow in it: a Process Pilot Study With Healthy Participants (HUMANITAS)
29 de julho de 2026 atualizado por: Pieter Maljaars, Leiden University Medical Center
The Effect of Soil Biodiversity on Human Gut Microbiome: a Process Pilot Study (The HUMANITAS Study)
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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
10
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jeroen Maljaars, MD, PhD
- Número de telefone: +31 71 526 3575
- E-mail: P.W.J.Maljaars@lumc.nl
Estude backup de contato
- Nome: Maarten Tushuizen, MD, PhD
- Número de telefone: +31 71 526 9111
- E-mail: M.E.Tushuizen@lumc.nl
Locais de estudo
-
-
South Holland
-
Leiden, South Holland, Holanda, 2333ZA
- Leids Universitair Medisch Centrum
-
Contato:
- Jeroen Maljaars, MD, PhD
- Número de telefone: +31 71 526 9111
- E-mail: P.W.J.Maljaars@lumc.nl
-
Investigador principal:
- Jeroen Maljaars, MD, PhD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Crops derived from Low followed by High diversity soil
Participants will be given vegetables, originating from low- or high-microbial diversity soil, to prepare smoothies with.
In this arm participants start with vegetables from a low diversity soil, after a washout period of two weeks they will receive vegetables from a high diversity soil.
|
Vegetable smoothie prepared with crops grown in low-microbial diversity soil
Vegetable smoothie prepared with crops grown in high-microbial diversity soil
|
|
Comparador Ativo: Crops derived from High followed by Low diversity soil
Participants will be given vegetables, originating from low- or high-microbial diversity soil, to prepare smoothies with.
In this arm participants start with vegetables from a high diversity soil, after a washout period of two weeks they will receive vegetables from a low diversity soil.
|
Vegetable smoothie prepared with crops grown in low-microbial diversity soil
Vegetable smoothie prepared with crops grown in high-microbial diversity soil
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of logistics of the study protocol: Deliveries
Prazo: 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.
|
From start enrollment to the end of treatment at 4 weeks
|
|
Feasibility of logistics of the study protocol: Preparation of the intervention product
Prazo: 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.
|
From the start of the treatment period until the end at 4 weeks
|
|
Feasibility of logistics of the study protocol: Recruitment rate
Prazo: From the start of recruitment until the start of the study
|
Number of recruited participants per month until the start of the study.
|
From the start of recruitment until the start of the study
|
|
Tracing back life microorganisms from the smoothie in stool samples
Prazo: 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
|
Day 1, Day 7, Day 22, and Day 28
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participant compliance to the study protocol
Prazo: 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.
|
From start enrolment until the end of treatment at the end of 4 weeks
|
|
Shifts in gut microbiome composition
Prazo: 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
|
Baseline, Day 8, Day 21, and Day 29
|
|
Sample completeness
Prazo: From start of treatment to the end of treatment at 4 weeks
|
percentage of complete sampling sets
|
From start of treatment to the end of treatment at 4 weeks
|
|
Asses willingness of participants to create their own intervention product
Prazo: 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.
|
From start treatment to end of treatment at 4 weeks
|
|
Differences in phytonutrient levels in serum
Prazo: 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
|
Baseline, Day 8, Day 21, and Day 29
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
- Albenberg LG, Wu GD. Diet and the intestinal microbiome: associations, functions, and implications for health and disease. Gastroenterology. 2014 May;146(6):1564-72. doi: 10.1053/j.gastro.2014.01.058. Epub 2014 Feb 4.
- Henao-Mejia J, Elinav E, Jin C, Hao L, Mehal WZ, Strowig T, Thaiss CA, Kau AL, Eisenbarth SC, Jurczak MJ, Camporez JP, Shulman GI, Gordon JI, Hoffman HM, Flavell RA. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature. 2012 Feb 1;482(7384):179-85. doi: 10.1038/nature10809.
- Clemente JC, Ursell LK, Parfrey LW, Knight R. The impact of the gut microbiota on human health: an integrative view. Cell. 2012 Mar 16;148(6):1258-70. doi: 10.1016/j.cell.2012.01.035.
- Turnbaugh PJ, Backhed F, Fulton L, Gordon JI. Diet-induced obesity is linked to marked but reversible alterations in the mouse distal gut microbiome. Cell Host Microbe. 2008 Apr 17;3(4):213-23. doi: 10.1016/j.chom.2008.02.015.
- Julious, S.A. (2005), Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist., 4: 287-291. https://doi.org/10.1002/pst.185
- Sanna S, van Zuydam NR, Mahajan A, Kurilshikov A, Vich Vila A, Vosa U, Mujagic Z, Masclee AAM, Jonkers DMAE, Oosting M, Joosten LAB, Netea MG, Franke L, Zhernakova A, Fu J, Wijmenga C, McCarthy MI. Causal relationships among the gut microbiome, short-chain fatty acids and metabolic diseases. Nat Genet. 2019 Apr;51(4):600-605. doi: 10.1038/s41588-019-0350-x. Epub 2019 Feb 18.
- Hirt H. Healthy soils for healthy plants for healthy humans: How beneficial microbes in the soil, food and gut are interconnected and how agriculture can contribute to human health. EMBO Rep. 2020 Aug 5;21(8):e51069. doi: 10.15252/embr.202051069. Epub 2020 Jul 31.
- Blum WEH, Zechmeister-Boltenstern S, Keiblinger KM. Does Soil Contribute to the Human Gut Microbiome? Microorganisms. 2019 Aug 23;7(9):287. doi: 10.3390/microorganisms7090287.
- Fierer N. Embracing the unknown: disentangling the complexities of the soil microbiome. Nat Rev Microbiol. 2017 Oct;15(10):579-590. doi: 10.1038/nrmicro.2017.87. Epub 2017 Aug 21.
- Leeming ER, Louca P, Gibson R, Menni C, Spector TD, Le Roy CI. The complexities of the diet-microbiome relationship: advances and perspectives. Genome Med. 2021 Jan 20;13(1):10. doi: 10.1186/s13073-020-00813-7.
- Johnson AJ, Zheng JJ, Kang JW, Saboe A, Knights D, Zivkovic AM. A Guide to Diet-Microbiome Study Design. Front Nutr. 2020 Jun 12;7:79. doi: 10.3389/fnut.2020.00079. eCollection 2020.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de setembro de 2026
Conclusão do estudo (Estimado)
1 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
16 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de julho de 2026
Primeira postagem (Real)
3 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- NL-010026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Metagenomic sequencing data from feces and pythonutrient levels in serum (if available)
Prazo de Compartilhamento de IPD
Beginning 1 month after publication with no end date
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .