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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paleolithic Diet | Experimental | Paleolithic Diet |
|
| General Healthful Diet | Active Comparator | General Healthful Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paleolithic diet | Other | Paleolithic diet |
| |
| General Healthful Diet |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The change between baseline and 4 weeks (post-intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The change between baseline and 4 weeks (post-intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal permeability | Change in intestinal permeability as measured by plasma zonulin levels | The change between baseline and 4 weeks (post-intervention). |
| Change in inflammatory markers | Change in inflammatory markers as measured by serum C-reactive protein levels |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pankaj Pasricha, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D066046 | Diet, Paleolithic |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Other |
General Healthful Diet |
|
| 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. | The change between baseline and 4 weeks (post-intervention). |
| 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. | The change between baseline and 4 weeks (post-intervention). |
| 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. | The change between baseline and 4 weeks (post-intervention). |
| 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. | The change between baseline and 4 weeks (post-intervention). |
| 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. | The change between baseline and 4 weeks (post-intervention). |
| 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. | The change between baseline and 4 weeks (post-intervention). |
| The change between baseline and 4 weeks (post-intervention). |
| Change in stool metabolomics | Change in stool metabolomics as measured by stool metabolite testing. | The change between baseline and 4 weeks (post-intervention). |
| Change in stool microbiome profile | 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. | 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. | 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. | 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. | Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies | The change between baseline and 4 weeks (post-intervention). |
| D004066 | Digestive System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |