Status:
COMPLETED
Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Diarrhea Predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purposes of this study are to prospectively determine the effect of a very low carbohydrate diet on quality of life and gastrointestinal symptoms in patients with diarrhea-predominant irritable bo...
Detailed Description
Approximately 10-15% of individuals in the United States have symptoms consistent with irritable bowel syndrome (IBS) which is a costly disorder and negatively impacts patient quality of life. The pat...
Eligibility Criteria
Inclusion
- Age 18-70 years old, male or female
- Meet Rome II Criteria for IBS-D
- Body mass index \> 25 kg/m\^2
- Desire to use a very low carbohydrate diet for weight loss
- Score of \> 36 on the FBDSI
- Ability to understand consent form
- In stable health by screening history, physical examination performed by a study physician, laboratory tests (normal blood counts, kidney function tests, liver tests, TSH).
Exclusion
- Age \< 18 years or age \> 70 years
- History of inflammatory bowel disease
- History of any gastrointestinal surgery that preceded the onset of IBS symptoms
- Pregnancy or breastfeeding
- FBDSI symptom score of ≤ 36
- Inability to understand consent form
- Diabetes requiring medications (must be controlled with diet and exercise alone).
- Chronic narcotic use for any reason
- Use of serotonin-selective reuptake inhibitors unless patient has been on a stable dose for at least 4 weeks.
- Use of any over-the-counter or prescription weight loss medications.
- Any chronic or unstable diseases (e.g., kidney disease, heart disease, or cancer) that may put the subject at increased risk from the intervention
- Any of the following baseline abnormalities of laboratory tests or physical exam findings:
- Serum creatinine \> 1.5 mg/dL in men, \> 1.3 mg/dL in women.
- Liver disease (AST or ALT \> 2 times the upper limit of normal or total bilirubin \> 1.6mg/dL).
- Blood pressure \> 160/100 mm Hg.
- Fasting triglycerides \> 600 mg/dL.
- Fasting serum low-density lipoprotein (LDL) cholesterol \> 190 mg/dL.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00616200
Start Date
August 1 2009
End Date
May 1 2010
Last Update
October 16 2017
Active Locations (1)
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1
UNC Center for Functional GI & Motility Disorders
Chapel Hill, North Carolina, United States, 27599