Trial Outcomes & Findings for Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS) (NCT NCT00616200)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

At the end of each of 6 study weeks

Results posted on

2017-10-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Two Week Standard Diet STARTED	17
Two Week Standard Diet COMPLETED	16
Two Week Standard Diet NOT COMPLETED	1
Four Week Very Low Carbohydrate Diet STARTED	16
Four Week Very Low Carbohydrate Diet COMPLETED	13
Four Week Very Low Carbohydrate Diet NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Four Week Very Low Carbohydrate Diet n=17 Participants A Very Low Carbohydrate Diet was administered for four weeks. VLCD = \<20g/day of carbohydrates
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment North America	17 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of each of 6 study weeks

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.

Outcome measures

Outcome measures
Measure	Four Week Very Low Carbohydrate Diet n=17 Participants A Very Low Carbohydrate Diet was administered for four weeks. VLCD = \<20g/day of carbohydrates
Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item.	13 Participants

SECONDARY outcome

Timeframe: 6 Weeks

Population: Analysis was per protocol analysis

Stool Frequency was measured as number of stools per day

Outcome measures

Outcome measures
Measure	Four Week Very Low Carbohydrate Diet n=17 Participants A Very Low Carbohydrate Diet was administered for four weeks. VLCD = \<20g/day of carbohydrates
Impact of Very Low Carbohydrate Diet on Stool Frequency	2.6 Stools Per day Standard Deviation .8

SECONDARY outcome

Timeframe: At the end of four week VLCD

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Four Week Very Low Carbohydrate Diet n=17 Participants A Very Low Carbohydrate Diet was administered for four weeks. VLCD = \<20g/day of carbohydrates
Sickness Impact Profile	2.3 Scores on a scale Standard Deviation 3.6

Adverse Events

Four Week Very Low Carbohydrate Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephan R. Weinland, Ph.D.

UNC Center for Functional GI & Motility Disorders

Phone: 9198437828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place