Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

NCT03035799 | Completed

• 1 other identifier: IRB00082222
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (7)

• Anxiety

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

• Depression

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

• Activity level

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

• Gastrointestinal symptoms

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

• Visceral sensitivity

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

Other Outcomes (8)

• Intestinal permeability

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

• Change in inflammatory markers

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

• Change in stool metabolomics

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

Study Arms (2)

Paleolithic Diet

EXPERIMENTAL

Paleolithic Diet

Other: Paleolithic diet

General Healthful Diet

ACTIVE COMPARATOR

General Healthful Diet

Other: General Healthful Diet

Interventions

Paleolithic diet OTHER

Paleolithic diet

Paleolithic Diet

General Healthful Diet OTHER

General Healthful Diet

General Healthful Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet, Paleolithic

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Pankaj Pasricha, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 30, 2017
• Study Start: April 24, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

US (1)