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NCT Number: NCT07586111

Effects 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

Recruiting

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, SE1 9NH, United Kingdom

Location status: Recruiting

Location contact

Clinical Trial Manager

CONTACT

[email protected]

+442078484552

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A diet containing plant foods

Other

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.

Other names: Study Diet A

A diet containing different plant foods

Other

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.

Other names: Study Diet B

Primary outcomes

  1. Alpha-diversity of the gut microbiota

    Time frame: Week 4

    The diversity of microbial taxa in faecal samples at 4 weeks assessed by calculating alpha-diversity score from 16S ribosomal RNA sequencing.

Secondary outcomes

  1. Absolute and change in alpha-diversity of the gut microbiota

    Time frame: Baseline, Week 4

    Absolute and change in alpha-diversity as measured by the diversity of micriobial taxa in faecal samples via 16S RNA sequencing.

  2. Beta-diversity of the gut microbiota

    Time frame: Baseline, Week 4

    The diversity of microbial taxa in faecal samples by calculating beta-diversity via 16S ribosomal RNA sequencing.

  3. Microbiota composition

    Time frame: Baseline, Week 4

    Absolute and change in microbiota composition of faecal samples between baseline and Week 4 as assessed by 16S ribosomal RNA sequencing.

  4. Targeted faecal and plasma metabolomics

    Time frame: Baseline, Week 4

    Absolute and change in short-chain fatty acids through Liquid Chromatography - Mass Spectrometry using validated assays.

  5. Targeted faecal and plasma metabolomics

    Time frame: Baseline, Week 4

    Absolute and change in bile acids through Liquid Chromatography - Mass Spectrometry using validated assays.

  6. Untargeted faecal metabolomics

    Time frame: Baseline, Week 4

    Metabolomics analysis via 1H NMR spectroscopy.

  7. Faecal water content via oven drying

    Time frame: Baseline, Week 4

    Absolute and change in water content of faecal samples assessed via oven drying.

  8. Stool frequency

    Time frame: Baseline, Week 4

    Absolute and change in stool frequency measured via prospective 7-day stool diary

  9. Stool consistency

    Time frame: Baseline, Week 4

    Absolute and change in stool consistency measured by Bristol stool form scale. Scale from 1 to 7.

  10. Gastrointestinal symptoms

    Time frame: 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.

  11. Endothelial function

    Time frame: Baseline, Week 4

    Flow mediated dilation measured via ultrasound of arm.

  12. Untargeted urine and plasma metabolomics

    Time frame: Baseline, Week 4

    Metabolomics measured via 1H NMR spectroscopy.

  13. Targeted plasma and urine metabolomics

    Time frame: Baseline, Week 4

    Metabolomics via Liquid Chromatography-Mass Spectroscopy using validated assays.

  14. Blood pressure

    Time frame: Baseline, Week 4

    Absolute and change in diastolic and systolic blood pressure.

  15. Body composition

    Time frame: Baseline, Week 4

    Absolute and change in body composition measured via biolelectrical impedance analysis (BIA).

  16. Waist circumference

    Time frame: Baseline, Week 4

    Absolute and change in waist circumference assessed by tape measure.

  17. Dietary intake

    Time frame: Baseline, Week 4

    Dietary intake measured by aggregating EPIC Norfolk food frequency questionnaire, daily food and drink diaries and food checklists.

  18. Biological markers of dietary intake

    Time frame: Baseline, Week 4

    Absolute and change in biomarkers of dietary intake as measured via validated assays.

Other outcomes

  1. Health-related Quality of Life

    Time frame: Baseline, Week 4

    Absolute and change in SF-36 questionnaire scores.

  2. Mental Health

    Time frame: Baseline, Week 4

    Absolute and change in Patient Health Questionnaire-8 and Anxiety and Depression Scale scores.

  3. Diet acceptability

    Time frame: Baseline, Week 4

    Acceptability of diet measured through a diet acceptability questionnaire containing multiple choice and open-ended questions.

  4. Diet satisfaction

    Time frame: 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.

  5. Dietary adherence

    Time frame: Baseline, Week 4

    Adherence to the intervention as measured by consumption of study meals, snacks and drinks.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

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

Registry information

Official study title

A Randomised Controlled Trial Investigating the Impact of Plant Foods on Gastrointestinal and Cardiometabolic Health

Acronym: PLANTIFUL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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