Back to resultsEffects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)
Primary Purpose
Diarrhea Predominant Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Very low carbohydrate diet
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea Predominant Irritable Bowel Syndrome focused on measuring D-IBS (diarrhea predominant irritable bowel syndrome)
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- UNC Center for Functional GI & Motility Disorders
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item.
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
Stool Frequency was measured as number of stools per day
Sickness Impact Profile
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.
Full Information
NCT ID
NCT00616200
First Posted
February 5, 2008
Last Updated
September 13, 2017
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT00616200
Brief Title
Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)
Official Title
The Effect of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome: A Prospective Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea Predominant Irritable Bowel Syndrome
Keywords
D-IBS (diarrhea predominant irritable bowel syndrome)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Very low carbohydrate diet
Intervention Description
4 weeks on strictly controlled low carbohydrate diet
Primary Outcome Measure Information:
Title
Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item.
Description
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.
Time Frame
At the end of each of 6 study weeks
Secondary Outcome Measure Information:
Title
Impact of Very Low Carbohydrate Diet on Stool Frequency
Description
Stool Frequency was measured as number of stools per day
Time Frame
6 Weeks
Title
Sickness Impact Profile
Description
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.
Time Frame
At the end of four week VLCD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Drossman, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Center for Functional GI & Motility Disorders
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19281859
Citation
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.
Results Reference
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Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)
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