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Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

5 de maio de 2020 atualizado por: Johns Hopkins University

A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

This pilot study proposes to gain a better understanding of the health benefits of the popular "paleo-diet" in patients with irritable bowel syndrome (IBS) and explore underlying mechanisms of benefit.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

In the proposed study, the primary hypothesis is that, compared with a customary diet, consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in patients with irritable bowel syndrome. Investigators also hypothesize consumption of the Paleolithic diet will result in decreased intestinal permeability, decreased inflammatory markers, and changes in the gut microbiome and microbiologic profiles.

Tipo de estudo

Intervencional

Inscrição (Real)

40

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

  • Estados Unidos
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Johns Hopkins University

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate anxiety or depression
  • Other causes of bowel symptoms excluded to the satisfaction of the Study Team
  • Age at least 18 years at initial screening visit
  • Patients who are able to sign and understand the study's informed consent form
  • Patients able to complete all screening evaluations and procedures

Exclusion Criteria:

  • Patients in inpatient hospital care
  • Severe or refractory bowel or psychological symptoms
  • Current consumption of a Paleolithic diet
  • Known Celiac disease
  • Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (TSH) level
  • Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater
  • Patients unable to speak English
  • Inability to obtain informed consent
  • Pregnant or nursing women
  • Any condition, which in the opinion of the investigator, would interfere with study requirements

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: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Paleolithic Diet
Outro: Paleolithic diet
Paleolithic diet
Comparador Ativo: General Healthful Diet
Outro: General Healthful Diet
General Healthful Diet

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Vitality
Prazo: The change between baseline and 4 weeks (post-intervention).
Vitality as measured on the vitality subscale of the short form health survey (SF36). This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys. The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life? Did you have a lot of energy? Did you feel worn out? Did you feel tired? The lower the score the more disability. The higher the score the less disability.
The change between baseline and 4 weeks (post-intervention).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Anxiety
Prazo: The change between baseline and 4 weeks (post-intervention).

Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire.

GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Depression
Prazo: The change between baseline and 4 weeks (post-intervention).

Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire.

PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Activity level
Prazo: The change between baseline and 4 weeks (post-intervention).
Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise. It is designed to be reliable valid and easy to complete quickly without a need for detailed review. Lower scores indicate less activity and higher scores equal more activity.
The change between baseline and 4 weeks (post-intervention).
Gastrointestinal symptoms
Prazo: The change between baseline and 4 weeks (post-intervention).

Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale

a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Visceral sensitivity
Prazo: The change between baseline and 4 weeks (post-intervention).
Visceral sensitivity as measured by the Visceral Sensitivity Index. Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Overall health status (Short Health Scale)
Prazo: The change between baseline and 4 weeks (post-intervention).
Overall health status as measured by the Short Health Scale questionnaires. The "Short Health Scale" is a 4-item questionnaire covering aspects of subjective health. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Overall health status (EQ-5D)
Prazo: The change between baseline and 4 weeks (post-intervention).
Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Intestinal permeability
Prazo: The change between baseline and 4 weeks (post-intervention).
Change in intestinal permeability as measured by plasma zonulin levels
The change between baseline and 4 weeks (post-intervention).
Change in inflammatory markers
Prazo: The change between baseline and 4 weeks (post-intervention).
Change in inflammatory markers as measured by serum C-reactive protein levels
The change between baseline and 4 weeks (post-intervention).
Change in stool metabolomics
Prazo: The change between baseline and 4 weeks (post-intervention).
Change in stool metabolomics as measured by stool metabolite testing.
The change between baseline and 4 weeks (post-intervention).
Change in stool microbiome profile
Prazo: The change between baseline and 4 weeks (post-intervention).
Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of urine.
Prazo: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool.
Prazo: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of saliva.
Prazo: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of blood.
Prazo: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).

Colaboradores e Investigadores

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

Patrocinador

Johns Hopkins University

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 (Real)

24 de abril de 2018

Conclusão Primária (Real)

1 de abril de 2020

Conclusão do estudo (Real)

1 de abril de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

18 de janeiro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de janeiro de 2017

Primeira postagem (Estimativa)

30 de janeiro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de maio de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de maio de 2020

Última verificação

1 de maio de 2020

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB00082222

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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