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Effects of Plant Foods on Gastrointestinal and Cardiometabolic Health (PLANTIFUL)

7 mei 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

248

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Study Diet A
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
Ander: A diet containing plant foods
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.
Andere namen:
  • Study Diet A
Actieve vergelijker: Study Diet B
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
Ander: A diet containing different plant foods
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.
Andere namen:
  • Study Diet B

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Alpha-diversity of the gut microbiota
Tijdsspanne: Week 4
The diversity of microbial taxa in faecal samples at 4 weeks assessed by calculating alpha-diversity score from 16S ribosomal RNA sequencing.
Week 4

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Absolute and change in alpha-diversity of the gut microbiota
Tijdsspanne: Baseline, Week 4
Absolute and change in alpha-diversity as measured by the diversity of micriobial taxa in faecal samples via 16S RNA sequencing.
Baseline, Week 4
Beta-diversity of the gut microbiota
Tijdsspanne: Baseline, Week 4
The diversity of microbial taxa in faecal samples by calculating beta-diversity via 16S ribosomal RNA sequencing.
Baseline, Week 4
Microbiota composition
Tijdsspanne: Baseline, Week 4
Absolute and change in microbiota composition of faecal samples between baseline and Week 4 as assessed by 16S ribosomal RNA sequencing.
Baseline, Week 4
Targeted faecal and plasma metabolomics
Tijdsspanne: Baseline, Week 4
Absolute and change in short-chain fatty acids through Liquid Chromatography - Mass Spectrometry using validated assays.
Baseline, Week 4
Targeted faecal and plasma metabolomics
Tijdsspanne: Baseline, Week 4
Absolute and change in bile acids through Liquid Chromatography - Mass Spectrometry using validated assays.
Baseline, Week 4
Untargeted faecal metabolomics
Tijdsspanne: Baseline, Week 4
Metabolomics analysis via 1H NMR spectroscopy.
Baseline, Week 4
Faecal water content via oven drying
Tijdsspanne: Baseline, Week 4
Absolute and change in water content of faecal samples assessed via oven drying.
Baseline, Week 4
Stool frequency
Tijdsspanne: Baseline, Week 4
Absolute and change in stool frequency measured via prospective 7-day stool diary
Baseline, Week 4
Stool consistency
Tijdsspanne: Baseline, Week 4
Absolute and change in stool consistency measured by Bristol stool form scale. Scale from 1 to 7.
Baseline, Week 4
Gastrointestinal symptoms
Tijdsspanne: Baseline, Week 4
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.
Baseline, Week 4
Endothelial function
Tijdsspanne: Baseline, Week 4
Flow mediated dilation measured via ultrasound of arm.
Baseline, Week 4
Untargeted urine and plasma metabolomics
Tijdsspanne: Baseline, Week 4
Metabolomics measured via 1H NMR spectroscopy.
Baseline, Week 4
Targeted plasma and urine metabolomics
Tijdsspanne: Baseline, Week 4
Metabolomics via Liquid Chromatography-Mass Spectroscopy using validated assays.
Baseline, Week 4
Blood pressure
Tijdsspanne: Baseline, Week 4
Absolute and change in diastolic and systolic blood pressure.
Baseline, Week 4
Body composition
Tijdsspanne: Baseline, Week 4
Absolute and change in body composition measured via biolelectrical impedance analysis (BIA).
Baseline, Week 4
Waist circumference
Tijdsspanne: Baseline, Week 4
Absolute and change in waist circumference assessed by tape measure.
Baseline, Week 4
Dietary intake
Tijdsspanne: Baseline, Week 4
Dietary intake measured by aggregating EPIC Norfolk food frequency questionnaire, daily food and drink diaries and food checklists.
Baseline, Week 4
Biological markers of dietary intake
Tijdsspanne: Baseline, Week 4
Absolute and change in biomarkers of dietary intake as measured via validated assays.
Baseline, Week 4

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Health-related Quality of Life
Tijdsspanne: Baseline, Week 4
Absolute and change in SF-36 questionnaire scores.
Baseline, Week 4
Mental Health
Tijdsspanne: Baseline, Week 4
Absolute and change in Patient Health Questionnaire-8 and Anxiety and Depression Scale scores.
Baseline, Week 4
Diet acceptability
Tijdsspanne: Baseline, Week 4
Acceptability of diet measured through a diet acceptability questionnaire containing multiple choice and open-ended questions.
Baseline, Week 4
Diet satisfaction
Tijdsspanne: Week 4
Absolute diet satisfaction measured by Food benefits assessment scale. Scored from 41 to 205 with a lower score indicating a higher diet satisfaction.
Week 4
Dietary adherence
Tijdsspanne: Baseline, Week 4
Adherence to the intervention as measured by consumption of study meals, snacks and drinks.
Baseline, Week 4

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

King's College London

Medewerkers

University of Leeds
University of Southampton
Biotechnology and Biological Sciences Research Council

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 april 2026

Primaire voltooiing (Geschat)

1 oktober 2028

Studie voltooiing (Geschat)

1 november 2028

Studieregistratiedata

Eerst ingediend

17 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 oktober 2025

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • HR-25/26-49752

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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