Effects of Plant Foods on Gastrointestinal and Cardiometabolic Health (PLANTIFUL)
2026年5月7日 更新者：King's College London
A Randomised Controlled Trial Investigating the Impact of Plant Foods on Gastrointestinal and Cardiometabolic Health
The aim of this randomised controlled trial is to investigate the effects of plant foods on gastrointestinal and cardiometabolic health in healthy adults aged 30-70 years old. The main question it will answer is "what is the effect of plant foods on alpha-diversity of the gut microbiota?".
Researchers will compare two diets containing plant foods to see if they have different effects on gastrointestinal and cardiometabolic health.
Participants will be asked to replace all their meals, snacks and drinks with those provided by the study team for four weeks (6 days/week). Participants will also be asked to attend the research facility on three occasions to:
- Provide a blood sample
- Provide a urine sample
- Provide a stool sample
- Have their body composition assessed
- Have an ultrasound of their artery (arm)
- Have their blood pressure measured
- Answer questionnaires related to dietary intake, mental health, physical activity, quality of life, diet acceptability and adherence
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
248
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。
研究場所
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London、イギリス、SE1 9NH
- 募集
- King's College London
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コンタクト：
- Clinical Trial Manager
- 電話番号：+442078484552
- メール：plantiful@kcl.ac.uk
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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:
- Adults aged 30-70 years of age
- Capacity to give informed consent in English
- Consume equal or less than the average UK plant food intake (number and quantity)
- Consume less than 30 g/d of fibre
- BMI 18.50-29.99 kg/m2
- Willing to complete the trial by adhering to the diet intervention, complete questionnaires, provide stool, urine and blood samples, record weight and other anthropometric values and record food intake throughout the study
- Willing and able to adhere to the protocol for the diet intervention for the whole duration of the trial (e.g., appropriate space in freezer to store meals, access to oven/microwave, no planned travelling)
- Willing to discontinue use of prebiotics and probiotics 4 weeks prior and during the intervention period
- Willing to consume animal products daily
- Medication use is stable in women receiving hormone replacement therapy (stable use for the past 3 months)
Exclusion Criteria:
- Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g., schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.
- A current diagnosis of IBS, as defined by the Rome IV criteria.
- Taking medications known to affect outcomes of interest, including:
- Prebiotics and probiotics 4 weeks prior to enrolment.
- Antibiotics within 4 weeks of enrolment.
- Medications known to affect blood pressure, appetite, gut motility, glucose control, or lipid levels within 4 weeks of enrolment.
- Taking any dietary supplements, apart from vitamin D or calcium supplements, 4 weeks prior to enrolment.
- Allergy or intolerance to any study food ingredients.
- Unable/dislike/unwilling to consume study foods or adhere to study protocol (e.g., not willing to drink a maximum 9 units of alcohol a week or consume animal products).
- Currently reported pregnant or lactating.
- Unwilling or unable to consume non-halal or non-kosher products.
- Estimated energy requirements of <1,500 kcal/day or >3,000 kcal/day.
- Unexplained or unintentional weight loss in the past six months.
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：並列代入
- 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：Study Diet A
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
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Study meals, snacks and drinks will be provided that contain plant foods for four weeks (6 days a week).
Participants will follow guidance in self-selecting foods on one day per week.
他の名前：
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アクティブコンパレータ：Study Diet B
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
|
Study meals, snacks and drinks will be provided that contain plant foods for four weeks (6 days a week).
Participants will follow guidance in self-selecting foods on one day per week.
他の名前：
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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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Alpha-diversity of the gut microbiota
時間枠：Week 4
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The diversity of microbial taxa in faecal samples at 4 weeks assessed by calculating alpha-diversity score from 16S ribosomal RNA sequencing.
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Week 4
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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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Absolute and change in alpha-diversity of the gut microbiota
時間枠：Baseline, Week 4
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Absolute and change in alpha-diversity as measured by the diversity of micriobial taxa in faecal samples via 16S RNA sequencing.
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Baseline, Week 4
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Beta-diversity of the gut microbiota
時間枠：Baseline, Week 4
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The diversity of microbial taxa in faecal samples by calculating beta-diversity via 16S ribosomal RNA sequencing.
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Baseline, Week 4
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Microbiota composition
時間枠：Baseline, Week 4
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Absolute and change in microbiota composition of faecal samples between baseline and Week 4 as assessed by 16S ribosomal RNA sequencing.
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Baseline, Week 4
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Targeted faecal and plasma metabolomics
時間枠：Baseline, Week 4
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Absolute and change in short-chain fatty acids through Liquid Chromatography - Mass Spectrometry using validated assays.
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Baseline, Week 4
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Targeted faecal and plasma metabolomics
時間枠：Baseline, Week 4
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Absolute and change in bile acids through Liquid Chromatography - Mass Spectrometry using validated assays.
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Baseline, Week 4
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Untargeted faecal metabolomics
時間枠：Baseline, Week 4
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Metabolomics analysis via 1H NMR spectroscopy.
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Baseline, Week 4
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Faecal water content via oven drying
時間枠：Baseline, Week 4
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Absolute and change in water content of faecal samples assessed via oven drying.
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Baseline, Week 4
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Stool frequency
時間枠：Baseline, Week 4
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Absolute and change in stool frequency measured via prospective 7-day stool diary
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Baseline, Week 4
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Stool consistency
時間枠：Baseline, Week 4
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Absolute and change in stool consistency measured by Bristol stool form scale. Scale from 1 to 7.
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Baseline, Week 4
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Gastrointestinal symptoms
時間枠：Baseline, Week 4
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Absolute and change in gastrointestincal symptons measured by Gastrointestinal symptoms rating scale score.
Scored from 15 to 105 with lower scores indicating less severe symptoms.
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Baseline, Week 4
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Endothelial function
時間枠：Baseline, Week 4
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Flow mediated dilation measured via ultrasound of arm.
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Baseline, Week 4
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Untargeted urine and plasma metabolomics
時間枠：Baseline, Week 4
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Metabolomics measured via 1H NMR spectroscopy.
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Baseline, Week 4
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Targeted plasma and urine metabolomics
時間枠：Baseline, Week 4
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Metabolomics via Liquid Chromatography-Mass Spectroscopy using validated assays.
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Baseline, Week 4
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Blood pressure
時間枠：Baseline, Week 4
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Absolute and change in diastolic and systolic blood pressure.
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Baseline, Week 4
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Body composition
時間枠：Baseline, Week 4
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Absolute and change in body composition measured via biolelectrical impedance analysis (BIA).
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Baseline, Week 4
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Waist circumference
時間枠：Baseline, Week 4
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Absolute and change in waist circumference assessed by tape measure.
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Baseline, Week 4
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Dietary intake
時間枠：Baseline, Week 4
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Dietary intake measured by aggregating EPIC Norfolk food frequency questionnaire, daily food and drink diaries and food checklists.
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Baseline, Week 4
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Biological markers of dietary intake
時間枠：Baseline, Week 4
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Absolute and change in biomarkers of dietary intake as measured via validated assays.
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Baseline, Week 4
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Health-related Quality of Life
時間枠：Baseline, Week 4
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Absolute and change in SF-36 questionnaire scores.
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Baseline, Week 4
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Mental Health
時間枠：Baseline, Week 4
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Absolute and change in Patient Health Questionnaire-8 and Anxiety and Depression Scale scores.
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Baseline, Week 4
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Diet acceptability
時間枠：Baseline, Week 4
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Acceptability of diet measured through a diet acceptability questionnaire containing multiple choice and open-ended questions.
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Baseline, Week 4
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Diet satisfaction
時間枠：Week 4
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Absolute diet satisfaction measured by Food benefits assessment scale.
Scored from 41 to 205 with a lower score indicating a higher diet satisfaction.
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Week 4
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Dietary adherence
時間枠：Baseline, Week 4
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Adherence to the intervention as measured by consumption of study meals, snacks and drinks.
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Baseline, Week 4
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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。
便利なリンク
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4月1日
一次修了 (推定)
2028年10月1日
研究の完了 (推定)
2028年11月1日
試験登録日
最初に提出
2026年4月17日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月7日
最終確認日
2025年10月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- HR-25/26-49752
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?
未定
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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