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

NCT00616200 | Completed Results

• 2 other identifiers: 05-2899GCRC 2392
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Keywords

D-IBS (diarrhea predominant irritable bowel syndrome)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Impact of Very Low Carbohydrate Diet on Stool Frequency

  6 Weeks

• Sickness Impact Profile

  At the end of four week VLCD

Study Arms (1)

A

EXPERIMENTAL

Other: Very low carbohydrate diet

Interventions

Very low carbohydrate diet OTHER

4 weeks on strictly controlled low carbohydrate diet

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Center for Functional GI & Motility Disorders

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 19281859 RESULT

Limitations and Caveats

Low N, lack of standard control group and specific overweight/obese female predominant population.

Results Point of Contact

• Title: Stephan R. Weinland, Ph.D.
• Organization: UNC Center for Functional GI & Motility Disorders

stephan_weinland@med.unc.edu

9198437828

Study Officials

• Douglas Drossman, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 15, 2008
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 16, 2017
• Results First Posted: November 11, 2011

Record last verified: 2011-10

Locations

US (1)