Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
5 mai 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Paleolithic Diet
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Paleolithic diet
|
|
Comparateur actif: General Healthful Diet
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General Healthful Diet
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Vitality
Délai: 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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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).
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intestinal permeability
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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).
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
24 avril 2018
Achèvement primaire (Réel)
1 avril 2020
Achèvement de l'étude (Réel)
1 avril 2020
Dates d'inscription aux études
Première soumission
18 janvier 2017
Première soumission répondant aux critères de contrôle qualité
25 janvier 2017
Première publication (Estimation)
30 janvier 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 mai 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mai 2020
Dernière vérification
1 mai 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00082222
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
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