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Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

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Johns Hopkins University

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Other: Paleolithic diet
Other: General Healthful Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03035799
IRB00082222

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

Paleolithic Diet
Experimental group
Description:
Paleolithic Diet
Treatment:
Other: Paleolithic diet
General Healthful Diet
Active Comparator group
Description:
General Healthful Diet
Treatment:
Other: General Healthful Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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