Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Paleolithic diet; Other: General Healthful Diet

• Registration Number: NCT03035799
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-30
• Study Start: 2018-04-24
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paleolithic Diet	Paleolithic diet	Paleolithic Diet
General Healthful Diet	General Healthful Diet	General Healthful Diet

Primary Outcome Measures

Name	Time	Method
Vitality	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety	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.
Depression	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.
Activity level	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.
Gastrointestinal symptoms	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.
Visceral sensitivity	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.
Overall health status (Short Health Scale)	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.
Overall health status (EQ-5D)	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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States