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



Status:Completed
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:10/18/2017
Start Date:August 2009
End Date:May 2010

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The Effect of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome: A Prospective Pilot Study

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 bowel syndrome (IBS-D); and to determine possible
physiological correlates of symptom improvement, as related to post-prandial
5-hydroxytryptamine (5-HT) release, weight loss and fiber content.

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 pathogenesis of this heterogeneous disorder is still not well
understood. Patients frequently identify worsening of symptoms after meals and often cite
particular foods as triggers of their IBS symptoms. Unfortunately, there is insufficient
randomized clinical trial data to allow for specific dietary recommendations. Previous
research has suggested a role for carbohydrate ingestion in IBS. There is also evidence for
the role of the post-prandial release of 5-hydroxytryptamine (5-HT) and its turnover (as
represented by the ratio of its metabolite, 5-hydroxyindoleacetic acid (5-HIAA), to 5-HT in
response to a carbohydrate-rich meal, especially in those with IBS-D. As the prevalence of
overweight (body mass index [BMI] > 25 kg/m2) and obesity (BMI > 30 kg/m2) has risen in
recent years, very low carbohydrate diets have become popular for those attempting to lose
weight. Patients with IBS, especially IBS-D, anecdotally report improvement in their
gastrointestinal symptoms after initiating a very low carbohydrate diet. However, no study
has investigated the effect of a very low carbohydrate diet on symptoms and quality of life
in patients with IBS-D.

Inclusion Criteria:

1. Age 18-70 years old, male or female

2. Meet Rome II Criteria for IBS-D

3. Body mass index > 25 kg/m^2

4. Desire to use a very low carbohydrate diet for weight loss

5. Score of > 36 on the FBDSI

6. Ability to understand consent form

7. 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 Criteria:

1. Age < 18 years or age > 70 years

2. History of inflammatory bowel disease

3. History of any gastrointestinal surgery that preceded the onset of IBS symptoms

4. Pregnancy or breastfeeding

5. FBDSI symptom score of ≤ 36

6. Inability to understand consent form

7. Diabetes requiring medications (must be controlled with diet and exercise alone).

8. Chronic narcotic use for any reason

9. Use of serotonin-selective reuptake inhibitors unless patient has been on a stable
dose for at least 4 weeks.

10. Use of any over-the-counter or prescription weight loss medications.

11. Any chronic or unstable diseases (e.g., kidney disease, heart disease, or cancer) that
may put the subject at increased risk from the intervention

12. Any of the following baseline abnormalities of laboratory tests or physical exam
findings:

1. Serum creatinine > 1.5 mg/dL in men, > 1.3 mg/dL in women.

2. Liver disease (AST or ALT > 2 times the upper limit of normal or total bilirubin
> 1.6mg/dL).

3. Blood pressure > 160/100 mm Hg.

4. Fasting triglycerides > 600 mg/dL.

5. Fasting serum low-density lipoprotein (LDL) cholesterol > 190 mg/dL.
We found this trial at
1
site
Chapel Hill, North Carolina 27514
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from
Chapel Hill, NC
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