Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

5 maj 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21287
        • Johns Hopkins University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Paleolithic Diet
Övrig: Paleolithic diet
Paleolithic diet
Aktiv komparator: General Healthful Diet
Övrig: General Healthful Diet
General Healthful Diet

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Vitality
Tidsram: 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).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Anxiety
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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).

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intestinal permeability
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johns Hopkins University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 april 2018

Primärt slutförande (Faktisk)

1 april 2020

Avslutad studie (Faktisk)

1 april 2020

Studieregistreringsdatum

Först inskickad

18 januari 2017

Först inskickad som uppfyllde QC-kriterierna

25 januari 2017

Första postat (Uppskatta)

30 januari 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 maj 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 maj 2020

Senast verifierad

1 maj 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00082222

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Irritabel tarmsyndrom

Kliniska prövningar på Paleolithic diet

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Ukraine

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera