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)
2026年7月29日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
10
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jeroen Maljaars, MD, PhD
- 電話番号：+31 71 526 3575
- メール：P.W.J.Maljaars@lumc.nl
研究連絡先のバックアップ
- 名前：Maarten Tushuizen, MD, PhD
- 電話番号：+31 71 526 9111
- メール：M.E.Tushuizen@lumc.nl
研究場所
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South Holland
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Leiden、South Holland、オランダ、2333ZA
- Leids Universitair Medisch Centrum
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コンタクト：
- Jeroen Maljaars, MD, PhD
- 電話番号：+31 71 526 9111
- メール：P.W.J.Maljaars@lumc.nl
-
主任研究者：
- Jeroen Maljaars, MD, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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Vegetable smoothie prepared with crops grown in low-microbial diversity soil
Vegetable smoothie prepared with crops grown in high-microbial diversity soil
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アクティブコンパレータ：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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of logistics of the study protocol: Deliveries
時間枠：From start enrollment to the end of treatment at 4 weeks
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The percentage of successful deliveries to the participants in the pre-agreed time window.
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From start enrollment to the end of treatment at 4 weeks
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Feasibility of logistics of the study protocol: Preparation of the intervention product
時間枠：From the start of the treatment period until the end at 4 weeks
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Using the Daily diary (Castor questionnaire), successful preparation of the intervention product is assessed.
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From the start of the treatment period until the end at 4 weeks
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Feasibility of logistics of the study protocol: Recruitment rate
時間枠：From the start of recruitment until the start of the study
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Number of recruited participants per month until the start of the study.
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From the start of recruitment until the start of the study
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Tracing back life microorganisms from the smoothie in stool samples
時間枠：Day 1, Day 7, Day 22, and Day 28
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Life bacteria present in the smoothies will be cultured and sequenced to then compare to feces samples of participants
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Day 1, Day 7, Day 22, and Day 28
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participant compliance to the study protocol
時間枠：From start enrolment until the end of treatment at the end of 4 weeks
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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.
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From start enrolment until the end of treatment at the end of 4 weeks
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Shifts in gut microbiome composition
時間枠：Baseline, Day 8, Day 21, and Day 29
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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
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Baseline, Day 8, Day 21, and Day 29
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Sample completeness
時間枠：From start of treatment to the end of treatment at 4 weeks
|
percentage of complete sampling sets
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From start of treatment to the end of treatment at 4 weeks
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Asses willingness of participants to create their own intervention product
時間枠：From start treatment to end of treatment at 4 weeks
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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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From start treatment to end of treatment at 4 weeks
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Differences in phytonutrient levels in serum
時間枠：Baseline, Day 8, Day 21, and Day 29
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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
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Baseline, Day 8, Day 21, and Day 29
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年9月1日
試験登録日
最初に提出
2026年7月16日
QC基準を満たした最初の提出物
2026年7月29日
最初の投稿 (実際)
2026年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月3日
QC基準を満たした最後の更新が送信されました
2026年7月29日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- NL-010026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Metagenomic sequencing data from feces and pythonutrient levels in serum (if available)
IPD 共有時間枠
Beginning 1 month after publication with no end date
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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