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Completed

NCT Number: NCT03035799

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paleolithic diet

Other

Paleolithic diet

General Healthful Diet

Other

General Healthful Diet

Primary outcomes

  1. Vitality

    Time frame: 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 outcomes

  1. Anxiety

    Time frame: 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.

  2. Depression

    Time frame: 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.

  3. Activity level

    Time frame: 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.

  4. Gastrointestinal symptoms

    Time frame: 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.

  5. Visceral sensitivity

    Time frame: 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.

  6. Overall health status (Short Health Scale)

    Time frame: 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.

  7. Overall health status (EQ-5D)

    Time frame: 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.

Other outcomes

  1. Intestinal permeability

    Time frame: The change between baseline and 4 weeks (post-intervention).

    Change in intestinal permeability as measured by plasma zonulin levels

  2. Change in inflammatory markers

    Time frame: The change between baseline and 4 weeks (post-intervention).

    Change in inflammatory markers as measured by serum C-reactive protein levels

  3. Change in stool metabolomics

    Time frame: The change between baseline and 4 weeks (post-intervention).

    Change in stool metabolomics as measured by stool metabolite testing.

  4. Change in stool microbiome profile

    Time frame: The change between baseline and 4 weeks (post-intervention).

    Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.

  5. Biobank specimen collection of urine.

    Time frame: The change between baseline and 4 weeks (post-intervention).

    Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies

  6. Biobank specimen collection of stool.

    Time frame: The change between baseline and 4 weeks (post-intervention).

    Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies

  7. Biobank specimen collection of saliva.

    Time frame: The change between baseline and 4 weeks (post-intervention).

    Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies

  8. Biobank specimen collection of blood.

    Time frame: The change between baseline and 4 weeks (post-intervention).

    Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2017
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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