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| ID | Type | Description | Link |
|---|---|---|---|
| GCRC 2392 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low carbohydrate diet | Other | 4 weeks on strictly controlled low carbohydrate diet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of each of 6 study weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Very Low Carbohydrate Diet on Stool Frequency | Stool Frequency was measured as number of stools per day | 6 Weeks |
| 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. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Drossman, MD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Center for Functional GI & Motility Disorders | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19281859 | Result | 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. |
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All patients responded to advertising in local media for participation in a research study looking at IBS-D. Patients presented to the General Clinical Research Center at the University of North Carolina. Each of the six weekly study visits and one baseline visit was conducted at the UNC GCRC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Diet Then Very Low Carbohydrate Diet | Two weeks of a carbohydrate rich diet was followed by four weeks of A Very Low Carbohydrate Diet. VLCD = <20g/day of carbohydrates |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Two Week Standard Diet |
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| Four Week Very Low Carbohydrate Diet |
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| ID | Title | Description |
|---|---|---|
| BG000 | Four Week Very Low Carbohydrate Diet | A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Participants | At the end of each of 6 study weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Four Week Very Low Carbohydrate Diet | A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates |
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Low N, lack of standard control group and specific overweight/obese female predominant population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan R. Weinland, Ph.D. | UNC Center for Functional GI & Motility Disorders | 9198437828 | stephan_weinland@med.unc.edu |
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| At the end of four week VLCD |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Impact of Very Low Carbohydrate Diet on Stool Frequency | Stool Frequency was measured as number of stools per day | Analysis was per protocol analysis | Posted | Mean | Standard Deviation | Stools Per day | 6 Weeks |
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| Secondary | 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. | The scoring range is from no impairment with a score of 0, to significant impairment, with 5. Changes in score of 3.5 are considered clinically significant. | Posted | Mean | Standard Deviation | Scores on a scale | At the end of four week VLCD |
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| 0 |
| 13 |
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| 13 |
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