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

7 de mayo de 2026 actualizado por: 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

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

248

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • London, Reino Unido, SE1 9NH
        • Reclutamiento
        • King's College London
        • Contacto:
          • Clinical Trial Manager
          • Número de teléfono: +442078484552
          • Correo electrónico: plantiful@kcl.ac.uk

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Study Diet A
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.
Otros nombres:
  • Study Diet A
Comparador activo: 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.
Otros nombres:
  • Study Diet B

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Alpha-diversity of the gut microbiota
Periodo de tiempo: 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

Medidas de resultado secundarias

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

Otras medidas de resultado

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de abril de 2026

Finalización primaria (Estimado)

1 de octubre de 2028

Finalización del estudio (Estimado)

1 de noviembre de 2028

Fechas de registro del estudio

Enviado por primera vez

17 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de mayo de 2026

Publicado por primera vez (Actual)

14 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de mayo de 2026

Última verificación

1 de octubre de 2025

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HR-25/26-49752

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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