Back to resultsComparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paleolithic diet
General Healthful Diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Paleolithic Diet
General Healthful Diet
Arm Description
Paleolithic Diet
General Healthful Diet
Outcomes
Primary Outcome Measures
Vitality
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.
Secondary Outcome Measures
Anxiety
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.
Depression
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.
Activity level
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.
Gastrointestinal symptoms
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.
Visceral sensitivity
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.
Overall health status (Short Health Scale)
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.
Overall health status (EQ-5D)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03035799
Brief Title
Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Official Title
A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paleolithic Diet
Arm Type
Experimental
Arm Description
Paleolithic Diet
Arm Title
General Healthful Diet
Arm Type
Active Comparator
Arm Description
General Healthful Diet
Intervention Type
Other
Intervention Name(s)
Paleolithic diet
Intervention Description
Paleolithic diet
Intervention Type
Other
Intervention Name(s)
General Healthful Diet
Intervention Description
General Healthful Diet
Primary Outcome Measure Information:
Title
Vitality
Description
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.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Secondary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Depression
Description
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.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Activity level
Description
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.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Gastrointestinal symptoms
Description
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.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Visceral sensitivity
Description
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.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Overall health status (Short Health Scale)
Description
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.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Overall health status (EQ-5D)
Description
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.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Other Pre-specified Outcome Measures:
Title
Intestinal permeability
Description
Change in intestinal permeability as measured by plasma zonulin levels
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Change in inflammatory markers
Description
Change in inflammatory markers as measured by serum C-reactive protein levels
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Change in stool metabolomics
Description
Change in stool metabolomics as measured by stool metabolite testing.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Change in stool microbiome profile
Description
Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Biobank specimen collection of urine.
Description
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Biobank specimen collection of stool.
Description
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Biobank specimen collection of saliva.
Description
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
Time Frame
The change between baseline and 4 weeks (post-intervention).
Title
Biobank specimen collection of blood.
Description
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
Time Frame
The change between baseline and 4 weeks (post-intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pankaj Pasricha, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
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