Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2020-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paleolithic Diet

Group Type EXPERIMENTAL

Paleolithic diet

Intervention Type OTHER

Paleolithic diet

General Healthful Diet

Group Type ACTIVE_COMPARATOR

General Healthful Diet

Intervention Type OTHER

General Healthful Diet

Interventions

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Paleolithic diet

Intervention Type OTHER

General Healthful Diet

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No