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

7. mai 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

248

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
      • London, Storbritannia, SE1 9NH
        • Rekruttering
        • King's College London
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Study Diet A
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
Annen: 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.
Andre navn:
  • Study Diet A
Aktiv komparator: Study Diet B
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
Annen: 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.
Andre navn:
  • Study Diet B

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Alpha-diversity of the gut microbiota
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Absolute and change in alpha-diversity of the gut microbiota
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Week 4
Absolute and change in bile acids through Liquid Chromatography - Mass Spectrometry using validated assays.
Baseline, Week 4
Untargeted faecal metabolomics
Tidsramme: Baseline, Week 4
Metabolomics analysis via 1H NMR spectroscopy.
Baseline, Week 4
Faecal water content via oven drying
Tidsramme: Baseline, Week 4
Absolute and change in water content of faecal samples assessed via oven drying.
Baseline, Week 4
Stool frequency
Tidsramme: Baseline, Week 4
Absolute and change in stool frequency measured via prospective 7-day stool diary
Baseline, Week 4
Stool consistency
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Week 4
Flow mediated dilation measured via ultrasound of arm.
Baseline, Week 4
Untargeted urine and plasma metabolomics
Tidsramme: Baseline, Week 4
Metabolomics measured via 1H NMR spectroscopy.
Baseline, Week 4
Targeted plasma and urine metabolomics
Tidsramme: Baseline, Week 4
Metabolomics via Liquid Chromatography-Mass Spectroscopy using validated assays.
Baseline, Week 4
Blood pressure
Tidsramme: Baseline, Week 4
Absolute and change in diastolic and systolic blood pressure.
Baseline, Week 4
Body composition
Tidsramme: Baseline, Week 4
Absolute and change in body composition measured via biolelectrical impedance analysis (BIA).
Baseline, Week 4
Waist circumference
Tidsramme: Baseline, Week 4
Absolute and change in waist circumference assessed by tape measure.
Baseline, Week 4
Dietary intake
Tidsramme: 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
Tidsramme: Baseline, Week 4
Absolute and change in biomarkers of dietary intake as measured via validated assays.
Baseline, Week 4

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health-related Quality of Life
Tidsramme: Baseline, Week 4
Absolute and change in SF-36 questionnaire scores.
Baseline, Week 4
Mental Health
Tidsramme: Baseline, Week 4
Absolute and change in Patient Health Questionnaire-8 and Anxiety and Depression Scale scores.
Baseline, Week 4
Diet acceptability
Tidsramme: Baseline, Week 4
Acceptability of diet measured through a diet acceptability questionnaire containing multiple choice and open-ended questions.
Baseline, Week 4
Diet satisfaction
Tidsramme: 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
Tidsramme: Baseline, Week 4
Adherence to the intervention as measured by consumption of study meals, snacks and drinks.
Baseline, Week 4

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

King's College London

Samarbeidspartnere

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

Publikasjoner og nyttige lenker

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Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. april 2026

Primær fullføring (Antatt)

1. oktober 2028

Studiet fullført (Antatt)

1. november 2028

Datoer for studieregistrering

Først innsendt

17. april 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2026

Sist bekreftet

1. oktober 2025

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HR-25/26-49752

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Nei

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