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

7 de maio de 2026 atualizado 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

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Estimado)

248

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • London, Reino Unido, SE1 9NH
        • Recrutamento
        • King's College London
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Outros nomes:
  • Study Diet A
Comparador Ativo: 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.
Outros nomes:
  • Study Diet B

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Alpha-diversity of the gut microbiota
Prazo: 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 resultados secundários

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

Outras medidas de resultado

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de abril de 2026

Conclusão Primária (Estimado)

1 de outubro de 2028

Conclusão do estudo (Estimado)

1 de novembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

17 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de maio de 2026

Última verificação

1 de outubro de 2025

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HR-25/26-49752

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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