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Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Douglas A Drossman, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00616200
First received: February 5, 2008
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
Results First Received: June 29, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diarrhea Predominant Irritable Bowel Syndrome
Intervention: Other: Very low carbohydrate diet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients responded to advertising in local media for participation in a research study looking at IBS-D. Patients presented to the General Clinical Research Center at the University of North Carolina. Each of the six weekly study visits and one baseline visit was conducted at the UNC GCRC.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Diet Then Very Low Carbohydrate Diet Two weeks of a carbohydrate rich diet was followed by four weeks of A Very Low Carbohydrate Diet. VLCD = <20g/day of carbohydrates

Participant Flow for 2 periods

 Period 1:   Two Week Standard Diet
    Standard Diet Then Very Low Carbohydrate Diet  
STARTED     17  
COMPLETED     16  
NOT COMPLETED     1  

Period 2:   Four Week Very Low Carbohydrate Diet
    Standard Diet Then Very Low Carbohydrate Diet  
STARTED     16  
COMPLETED     13  
NOT COMPLETED     3  



  Baseline Characteristics
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Reporting Groups
  Description
Four Week Very Low Carbohydrate Diet A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates

Baseline Measures
    Four Week Very Low Carbohydrate Diet  
Number of Participants  
[units: participants]
 		  17  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  46  ± 10  
Gender  
[units: participants]
 		 
Female     15  
Male     2  
Region of Enrollment  
[units: participants]
 		 
North America     17  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item.   [ Time Frame: At the end of each of 6 study weeks ]
  Show Outcome Measure 1

2.  Secondary:   Impact of Very Low Carbohydrate Diet on Stool Frequency   [ Time Frame: 6 Weeks ]
  Show Outcome Measure 2

3.  Secondary:   Sickness Impact Profile   [ Time Frame: At the end of four week VLCD ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Low N, lack of standard control group and specific overweight/obese female predominant population.  


Results Point of Contact:  
Name/Title: Stephan R. Weinland, Ph.D.
Organization: UNC Center for Functional GI & Motility Disorders
phone: 9198437828
e-mail: stephan_weinland@med.unc.edu


Publications of Results:


Responsible Party: Douglas A Drossman, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00616200     History of Changes
Other Study ID Numbers: 05-2899, GCRC 2392
Study First Received: February 5, 2008
Results First Received: June 29, 2010
Last Updated: October 5, 2011
Health Authority: United States: Institutional Review Board