Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Diarrhea Predominant Irritable Bowel Syndrome
Other: Very low carbohydrate diet
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome: A Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    Adequate relief was measured as the primary endpoint via a single item Adequate Relief Question asking "Over the past week have you had adequate relief of your symptom experience". Higher scores represent greater levels of adequate relief over the week prior to the assessment. Participants completed this 1-item questionnaire at the end of each of weeks of the study, assessing whether they had adequate relief of their IBS symptoms for the week.

    A responder was defined as reporting adequate relief in at least 2 of the 4 weeks on the VLCD.



Secondary Outcome Measures:
  • Impact of Very Low Carbohydrate Diet on Stool Frequency [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Stool Frequency was measured as number of stools per day

  • Sickness Impact Profile [ Time Frame: At the end of four week VLCD ] [ Designated as safety issue: No ]
    Units of measurement on the Sickness Impact Profile were ordinal rated scored. Information on scoring use and interpretation of the Sickness Impact Profile, readers are encouraged to read Bergner et. al. 1981 - Bergner, M., Bobbit, R.A., Carter, W.B. et all (1981) the Sickness Impact Profile: Development and final revision of a health status measure. Medical Care, 19:787-805 The SIP measures sickness-related dysfunction based on behavior in order to provide a measure of health status that will aid in assessing the outcome of health care services.


Enrollment: 17
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Other: Very low carbohydrate diet
4 weeks on strictly controlled low carbohydrate diet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616200

Locations
United States, North Carolina
UNC Center for Functional GI & Motility Disorders
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Douglas A Drossman, MD
Investigators
Principal Investigator: Douglas Drossman, MD UNC Chapel Hill
  More Information

Publications:
Responsible Party: Douglas A Drossman, MD, Professor of Medicine, 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

Keywords provided by University of North Carolina, Chapel Hill:
D-IBS (diarrhea predominant irritable bowel syndrome)

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014