- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03035799
Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Paleolithic Diet
|
Paleolithic diet
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Aktiv komparator: General Healthful Diet
|
General Healthful Diet
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Vitality
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Anxiety
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Intestinal permeability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00082222
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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