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

NCT ID: NCT00616200

Last Updated: 2017-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-05-31

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 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.

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 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.

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Keywords

D-IBS (diarrhea predominant irritable bowel syndrome)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Very low carbohydrate diet

Intervention Type: OTHER

4 weeks on strictly controlled low carbohydrate diet

Interventions

Very low carbohydrate diet

4 weeks on strictly controlled low carbohydrate diet

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Drossman, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

UNC Center for Functional GI & Motility Disorders

Chapel Hill, North Carolina, United States

Countries

United States

References

Austin GL, Dalton CB, Hu Y, Morris CB, Hankins J, Weinland SR, Westman EC, Yancy WS Jr, Drossman DA. A very low-carbohydrate diet improves symptoms and quality of life in diarrhea-predominant irritable bowel syndrome. Clin Gastroenterol Hepatol. 2009 Jun;7(6):706-708.e1. doi: 10.1016/j.cgh.2009.02.023. Epub 2009 Mar 10.

Reference Type: RESULT

PMID: 19281859 (View on PubMed)

Other Identifiers

GCRC 2392

Identifier Type: -

Identifier Source: secondary_id

05-2899

Identifier Type: -

Identifier Source: org_study_id