Trial Outcomes & Findings for Dietary Carbohydrate and GERD in Veterans (NCT NCT02384551)
NCT ID: NCT02384551
Last Updated: 2024-09-19
Results Overview
ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
24 hours
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
HTHS
High total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
HTLS
High total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTHS
Low total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTLS
Low total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
40
|
36
|
39
|
|
Overall Study
COMPLETED
|
22
|
26
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
14
|
14
|
Reasons for withdrawal
| Measure |
HTHS
High total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
HTLS
High total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTHS
Low total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTLS
Low total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
14
|
14
|
14
|
Baseline Characteristics
Dietary Carbohydrate and GERD in Veterans
Baseline characteristics by cohort
| Measure |
HTHS
n=22 Participants
High total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
HTLS
n=26 Participants
High total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTHS
n=22 Participants
Low total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTLS
n=25 Participants
Low total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
95 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
58.4 years
STANDARD_DEVIATION 15.3 • n=107 Participants
|
56.0 years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
59.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 12.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
80 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
95 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 24 hoursambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs
Outcome measures
| Measure |
HTHS
n=22 Participants
High total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
HTLS
n=26 Participants
High total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTHS
n=22 Participants
Low total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTLS
n=25 Participants
Low total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
|---|---|---|---|---|
|
Gastroesophageal pH
|
7.3 percent time ph < 4 in 24 hrs
Standard Deviation 12.1
|
6.6 percent time ph < 4 in 24 hrs
Standard Deviation 8.4
|
3.7 percent time ph < 4 in 24 hrs
Standard Deviation 4.2
|
4.9 percent time ph < 4 in 24 hrs
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 9 weeksGERD symptoms using Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score, score is based on a scale, from 0-18, with higher score indicating more symptoms. There is not a measure of central tendency, just the total score as reported.
Outcome measures
| Measure |
HTHS
n=22 Participants
High total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
HTLS
n=26 Participants
High total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTHS
n=22 Participants
Low total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTLS
n=25 Participants
Low total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
|---|---|---|---|---|
|
Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score
|
5.1 final score
Standard Deviation 3.8
|
3.2 final score
Standard Deviation 3.1
|
4.5 final score
Standard Deviation 4.5
|
3.5 final score
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 9 weeksGERD symptoms measured as Gastroesophageal Scale Assessment Symptom (GSAS) score. Scores range from 0-45, with higher scores indicating more symptoms. Not a measure of central tendency.
Outcome measures
| Measure |
HTHS
n=22 Participants
High total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
HTLS
n=26 Participants
High total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTHS
n=22 Participants
Low total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTLS
n=25 Participants
Low total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
|---|---|---|---|---|
|
Gastroesophageal Scale Assessment Symptom (GSAS) Score
|
5.6 total score
Standard Deviation 2.4
|
4.1 total score
Standard Deviation 2.0
|
5.6 total score
Standard Deviation 2.3
|
4.5 total score
Standard Deviation 2.1
|
Adverse Events
HTHS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HTLS
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
LTHS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LTLS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HTHS
n=35 participants at risk
High total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
HTLS
n=40 participants at risk
High total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTHS
n=36 participants at risk
Low total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
LTLS
n=39 participants at risk
Low total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification
|
|---|---|---|---|---|
|
Gastrointestinal disorders
pill stuck in throat
|
0.00%
0/35 • 9 weeks
no difference
|
2.5%
1/40 • Number of events 1 • 9 weeks
no difference
|
0.00%
0/36 • 9 weeks
no difference
|
0.00%
0/39 • 9 weeks
no difference
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place