Trial Outcomes & Findings for A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients (NCT NCT04065048)
NCT ID: NCT04065048
Last Updated: 2024-12-17
Results Overview
The primary aim will measure the Crohn's Disease Activity Index (CDAI) at the enrollment and end of study visit. CDAI scores can range from 0 to \~600 (A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease). Herein, a cut-off value of \<150 was selected so that most patients below this threshold would be rated by physicians as 'very well'. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point \[i.e., value at 7 days (post) minus value at baseline/enrollment (pre)\].
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
7 days
Results posted on
2024-12-17
Participant Flow
Participant milestones
| Measure |
Crohn's on Soy Diet
Participants with Crohn's disease randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Soy based diet: The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
|
Crohn's on Non-Soy Diet
Participants with Crohn's disease randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Non-soy based diet: Diet of identical composition to the soy diet with the exception of soy.
|
Healthy Controls on Soy Diet
Healthy participants (without Crohn's disease) randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Soy based diet: The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
|
Healthy Controls on Non-Soy Diet
Healthy participants (without Crohn's disease) randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Non-soy based diet: Diet of identical composition to the soy diet with the exception of soy.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Crohn's on Soy Diet
Participants with Crohn's disease randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Soy based diet: The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
|
Crohn's on Non-Soy Diet
Participants with Crohn's disease randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Non-soy based diet: Diet of identical composition to the soy diet with the exception of soy.
|
Healthy Controls on Soy Diet
Healthy participants (without Crohn's disease) randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Soy based diet: The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
|
Healthy Controls on Non-Soy Diet
Healthy participants (without Crohn's disease) randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Non-soy based diet: Diet of identical composition to the soy diet with the exception of soy.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients
Baseline characteristics by cohort
| Measure |
Crohn's on Soy Diet
n=16 Participants
Participants with Crohn's disease randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
.
|
Crohn's on Non-Soy Diet
n=15 Participants
Participants with Crohn's disease randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
|
Healthy Controls on Soy Diet
n=14 Participants
Healthy participants (without Crohn's disease) randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
|
Healthy Controls on Non-Soy Diet
n=15 Participants
Healthy participants (without Crohn's disease) randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.43 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
48.53 years
STANDARD_DEVIATION 11.30 • n=7 Participants
|
36.14 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 14.25 • n=4 Participants
|
41.55 years
STANDARD_DEVIATION 13.71 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
15 participants
n=4 Participants
|
60 participants
n=21 Participants
|
|
Body Mass Index
|
29.15 kg/m^2
STANDARD_DEVIATION 6.34 • n=5 Participants
|
30.23 kg/m^2
STANDARD_DEVIATION 6.46 • n=7 Participants
|
28.32 kg/m^2
STANDARD_DEVIATION 6.19 • n=5 Participants
|
28.74 kg/m^2
STANDARD_DEVIATION 5.78 • n=4 Participants
|
28.93 kg/m^2
STANDARD_DEVIATION 6.32 • n=21 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe primary aim will measure the Crohn's Disease Activity Index (CDAI) at the enrollment and end of study visit. CDAI scores can range from 0 to \~600 (A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease). Herein, a cut-off value of \<150 was selected so that most patients below this threshold would be rated by physicians as 'very well'. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point \[i.e., value at 7 days (post) minus value at baseline/enrollment (pre)\].
Outcome measures
| Measure |
Crohn's Patients on Soy Diet
n=16 Participants
CDAI value at 7 days minus value at baseline
|
Crohn's Patients on Non-soy Diet
n=15 Participants
CDAI value at 7 days minus value at baseline
|
Healthy Controls on Soy Diet
Healthy participants (without Crohn's disease) randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Soy based diet: The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
|
Healthy Controls on Non-Soy Diet
Healthy participants (without Crohn's disease) randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Non-soy based diet: Diet of identical composition to the soy diet with the exception of soy.
|
|---|---|---|---|---|
|
Maintenance of Symptomatic Remission, Without Worsening of Any Existing Disease Activity During Study Period
|
-31.63 score on a scale
Standard Deviation 57.91
|
-27.57 score on a scale
Standard Deviation 56.62
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 daysChange in fecal myleoperoxidase (MPO) activity at day 7 vs day 0.
Outcome measures
| Measure |
Crohn's Patients on Soy Diet
n=16 Participants
CDAI value at 7 days minus value at baseline
|
Crohn's Patients on Non-soy Diet
n=15 Participants
CDAI value at 7 days minus value at baseline
|
Healthy Controls on Soy Diet
n=14 Participants
Healthy participants (without Crohn's disease) randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Soy based diet: The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
|
Healthy Controls on Non-Soy Diet
n=15 Participants
Healthy participants (without Crohn's disease) randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Non-soy based diet: Diet of identical composition to the soy diet with the exception of soy.
|
|---|---|---|---|---|
|
Change in Fecal Myleoperoxidase (MPO) Activity
|
-0.691 ug/mg
Standard Deviation 1.471
|
0.7336 ug/mg
Standard Deviation 1.483
|
-0.0995 ug/mg
Standard Deviation 0.767
|
0.5209 ug/mg
Standard Deviation 1.036
|
SECONDARY outcome
Timeframe: measured after the 7-day diet interventionSecondary outcome will focus on changes to the functional composition of fecal gut microbiota, including bacterial butryate production after the diet intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: participants who responded to 6 month survey
To assess the percentage of patients who intend to continue the study diets when prepared food is no longer provided without cost, and the reasons for discontinuation of either diet (compared to resuming usual food habits).
Outcome measures
| Measure |
Crohn's Patients on Soy Diet
n=12 Participants
CDAI value at 7 days minus value at baseline
|
Crohn's Patients on Non-soy Diet
n=8 Participants
CDAI value at 7 days minus value at baseline
|
Healthy Controls on Soy Diet
n=7 Participants
Healthy participants (without Crohn's disease) randomly assigned the Soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Soy based diet: The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
|
Healthy Controls on Non-Soy Diet
n=6 Participants
Healthy participants (without Crohn's disease) randomly assigned the non-Soy diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Non-soy based diet: Diet of identical composition to the soy diet with the exception of soy.
|
|---|---|---|---|---|
|
Percentage of Subjects Who Continue Diet Following Completion of Study
|
8 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
Adverse Events
Crohn's on Soy Diet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Crohn's on Non-Soy Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls on Soy Diet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy Controls on Non-Soy 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
| Measure |
Crohn's on Soy Diet
n=16 participants at risk
Participants with Crohn's disease randomly assigned the Soy-based diet for 7 days.
|
Crohn's on Non-Soy Diet
n=15 participants at risk
Participants with Crohn's disease randomly assigned the non-Soy diet for 7 days.
|
Healthy Controls on Soy Diet
n=14 participants at risk
Healthy participants (without Crohn's disease) randomly assigned the Soy-based diet for 7 days
|
Healthy Controls on Non-Soy Diet
n=15 participants at risk
Healthy participants (without Crohn's disease) randomly assigned the non-Soy diet for 7 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected over the 7 day diet intervention period
|
0.00%
0/15 • Adverse event data was collected over the 7 day diet intervention period
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected over the 7 day diet intervention period
|
0.00%
0/15 • Adverse event data was collected over the 7 day diet intervention period
|
Additional Information
Abigail Raffner Basson, Principal Investigator & Study Coordinator
Case Western Reserve University
Phone: 2163276003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place