Trial Outcomes & Findings for Safety and Tolerability of Soy Fiber (NCT NCT04499482)
NCT ID: NCT04499482
Last Updated: 2023-05-18
Results Overview
Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
One week at each dose
Results posted on
2023-05-18
Participant Flow
The study enrolled 8 subjects. Each subject started at the 10g soy flour dose and crossed over to the 20 g soy flour dose after one week if they tolerated the 10 g soy flour dose, and subsequently to the 30g soy flour dose if they tolerated the 20g soy flour dose.
Participant milestones
| Measure |
Foods Containing 10 g Soy Flour
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|
|
Foods Containing 10 g Soy Flour
STARTED
|
8
|
|
Foods Containing 10 g Soy Flour
COMPLETED
|
7
|
|
Foods Containing 10 g Soy Flour
NOT COMPLETED
|
1
|
|
Foods Containing 20 g Soy Flour
STARTED
|
7
|
|
Foods Containing 20 g Soy Flour
COMPLETED
|
7
|
|
Foods Containing 20 g Soy Flour
NOT COMPLETED
|
0
|
|
Foods Containing 30g Soy Flour
STARTED
|
7
|
|
Foods Containing 30g Soy Flour
COMPLETED
|
7
|
|
Foods Containing 30g Soy Flour
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Foods Containing 10 g Soy Flour
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|
|
Foods Containing 10 g Soy Flour
One subject dropped from the study at Day 3 as the subject could not meet the demands of the study
|
1
|
Baseline Characteristics
One subject dropped from the study at day 3 of week one and was not included in the analysis
Baseline characteristics by cohort
| Measure |
All Study Participants
n=7 Participants
Participants will receive foods containing 10g, 20g, and 30g of soy flour to be consumed everyday for one week at each dose.
Food: Soy-fiber containing food
|
|---|---|
|
Age, Continuous
|
73 Years
STANDARD_DEVIATION 2 • n=5 Participants • One subject dropped from the study at day 3 of week one and was not included in the analysis
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis.
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • One subject dropped from the study at Day 3 of week one and was not included in the analysis.
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants • Each of the seven subjects crossed over to the next treatment
|
|
Body Mass Index
|
34 kg/m^2
STANDARD_DEVIATION 2.8 • n=5 Participants • Each of the seven subjects crossed over to the next treatment
|
PRIMARY outcome
Timeframe: One week at each dosePopulation: One subject dropped from the study at Day 3 of week one and was not included in the analysis.
Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
n=7 Participants
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
n=7 Participants
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: One weekPopulation: One subject dropped from the study at Day 3 of week one and was excluded from the analysis.
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
10 g Soy-related Gastrointestinal Symptoms
Bloating · Mild
|
1 Participants
|
—
|
—
|
|
10 g Soy-related Gastrointestinal Symptoms
Bloating · None
|
6 Participants
|
—
|
—
|
|
10 g Soy-related Gastrointestinal Symptoms
Abdominal Rumbling · Mild
|
2 Participants
|
—
|
—
|
|
10 g Soy-related Gastrointestinal Symptoms
Abdominal Rumbling · None
|
5 Participants
|
—
|
—
|
|
10 g Soy-related Gastrointestinal Symptoms
Flatulence · Mild
|
2 Participants
|
—
|
—
|
|
10 g Soy-related Gastrointestinal Symptoms
Flatulence · None
|
5 Participants
|
—
|
—
|
|
10 g Soy-related Gastrointestinal Symptoms
Abdominal Pain · Mild
|
0 Participants
|
—
|
—
|
|
10 g Soy-related Gastrointestinal Symptoms
Abdominal Pain · None
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One weekPopulation: One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
20 g Soy-related Gastrointestinal Symptoms
Bloating · Mild
|
0 Participants
|
—
|
—
|
|
20 g Soy-related Gastrointestinal Symptoms
Bloating · None
|
7 Participants
|
—
|
—
|
|
20 g Soy-related Gastrointestinal Symptoms
Abdominal Rumbling · Mild
|
1 Participants
|
—
|
—
|
|
20 g Soy-related Gastrointestinal Symptoms
Abdominal Rumbling · None
|
6 Participants
|
—
|
—
|
|
20 g Soy-related Gastrointestinal Symptoms
Flatulence · Mild
|
5 Participants
|
—
|
—
|
|
20 g Soy-related Gastrointestinal Symptoms
Flatulence · None
|
2 Participants
|
—
|
—
|
|
20 g Soy-related Gastrointestinal Symptoms
Abdominal pain · Mild
|
0 Participants
|
—
|
—
|
|
20 g Soy-related Gastrointestinal Symptoms
Abdominal pain · None
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One weekPopulation: One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
30 g Soy-related Gastrointestinal Symptoms
Bloating · Mild
|
1 Participants
|
—
|
—
|
|
30 g Soy-related Gastrointestinal Symptoms
Bloating · None
|
6 Participants
|
—
|
—
|
|
30 g Soy-related Gastrointestinal Symptoms
Abdominal Rumbling · Mild
|
1 Participants
|
—
|
—
|
|
30 g Soy-related Gastrointestinal Symptoms
Abdominal Rumbling · None
|
6 Participants
|
—
|
—
|
|
30 g Soy-related Gastrointestinal Symptoms
Flatulence · Mild
|
5 Participants
|
—
|
—
|
|
30 g Soy-related Gastrointestinal Symptoms
Flatulence · None
|
2 Participants
|
—
|
—
|
|
30 g Soy-related Gastrointestinal Symptoms
Abdominal Pain · Mild
|
1 Participants
|
—
|
—
|
|
30 g Soy-related Gastrointestinal Symptoms
Abdominal Pain · None
|
6 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One weekPopulation: One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
10 g Soy-related Stool Frequency
1-2
|
2 Participants
|
—
|
—
|
|
10 g Soy-related Stool Frequency
3-4
|
4 Participants
|
—
|
—
|
|
10 g Soy-related Stool Frequency
5-6
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One weekSubjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
20 g Soy-related Stool Frequency
1-2
|
1 Participants
|
—
|
—
|
|
20 g Soy-related Stool Frequency
3-4
|
5 Participants
|
—
|
—
|
|
20 g Soy-related Stool Frequency
5-6
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One weekSubjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
30 g Soy-related Stool Frequency
1-2
|
1 Participants
|
—
|
—
|
|
30 g Soy-related Stool Frequency
3-4
|
3 Participants
|
—
|
—
|
|
30 g Soy-related Stool Frequency
5-6
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One weekSubjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
10 Soy-related Stool Consistency
3, Normal (Like sausage but with cracks)
|
2 Participants
|
—
|
—
|
|
10 Soy-related Stool Consistency
4, Normal (Like sausage, smooth and soft
|
3 Participants
|
—
|
—
|
|
10 Soy-related Stool Consistency
5, Normal (Soft blobs with clear cut edges)
|
2 Participants
|
—
|
—
|
|
10 Soy-related Stool Consistency
1, Abnormal(Separate hard lumps)
|
0 Participants
|
—
|
—
|
|
10 Soy-related Stool Consistency
2, Abnormal (Sausage-shaped but lumpy)
|
0 Participants
|
—
|
—
|
|
10 Soy-related Stool Consistency
6, Abnormal (Fluffy pieces with ragged edges)
|
0 Participants
|
—
|
—
|
|
10 Soy-related Stool Consistency
7, Abnormal (Watery)
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One weekPopulation: One subject was dropped from the study on Day 3 of week 1 and was not included in the analysis
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
20 g Soy-related Stool Consistency
5, Normal (Soft blobs with clear-cut edges)
|
2 Participants
|
—
|
—
|
|
20 g Soy-related Stool Consistency
1, Abnormal (Separate hard lumps)
|
0 Participants
|
—
|
—
|
|
20 g Soy-related Stool Consistency
2, Abnormal (Sausage-shaped but lumpy)
|
0 Participants
|
—
|
—
|
|
20 g Soy-related Stool Consistency
6, Abnormal (Fluffy pieces with ragged edges)
|
0 Participants
|
—
|
—
|
|
20 g Soy-related Stool Consistency
7, Abnormal (Watery)
|
0 Participants
|
—
|
—
|
|
20 g Soy-related Stool Consistency
3, Normal (Like a sausage, but with cracks)
|
0 Participants
|
—
|
—
|
|
20 g Soy-related Stool Consistency
4, Normal (Like sausage, smooth and soft)
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One weekPopulation: One subject was dropped from the study at Day 3 and was not included in the analysis
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
30 g Soy-related Stool Consistency
3, Normal (Like a sausage but with cracks)
|
0 Participants
|
—
|
—
|
|
30 g Soy-related Stool Consistency
4, Normal (Like a sausage, smooth and soft)
|
2 Participants
|
—
|
—
|
|
30 g Soy-related Stool Consistency
5, Normal (Soft blobs with clear-cut edges)
|
4 Participants
|
—
|
—
|
|
30 g Soy-related Stool Consistency
1, Abnormal (Separate hard lumps)
|
1 Participants
|
—
|
—
|
|
30 g Soy-related Stool Consistency
2, Abnormal (Sausage-shaped but lumpy)
|
0 Participants
|
—
|
—
|
|
30 g Soy-related Stool Consistency
6, Abnormal (Fluffy pieces with ragged edges)
|
0 Participants
|
—
|
—
|
|
30 g Soy-related Stool Consistency
7, Abnormal (Watery)
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: One weekPopulation: One subject was dropped from the study at Day 3 and was excluded from the analysis
Measurement of fecal short chain fatty acids in response to intake of soy
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
10 g Soy Intake Effect on Fecal Short Chain Fatty Acids
|
5736.93 mg fecal short chain fatty acids/g dry f
Standard Error 1615.02
|
—
|
—
|
SECONDARY outcome
Timeframe: One weekPopulation: One subject was dropped from the study at Day 3 and was excluded from the analysis.
Measurement of fecal short chain fatty acids in response to intake of soy
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
20 g Soy Intake Effect on Fecal Short Chain Fatty Acids
|
6577.87 mg fecal short chain fatty acids/g dry f
Standard Error 1615.02
|
—
|
—
|
SECONDARY outcome
Timeframe: One weekPopulation: One subject was dropped from the study at Day 3 and was excluded from the analysis
Measurement of fecal short chain fatty acids in response to intake of soy
Outcome measures
| Measure |
Foods Containing 10 g Soy Flour
n=7 Participants
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20 g Soy Flour
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30 g Soy Flour
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
30 g Soy Intake Effect on Fecal Short Chain Fatty Acids
|
6191.89 mg fecal short chain fatty acids/g dry f
Standard Error 1615.02
|
—
|
—
|
Adverse Events
Foods Containing 10g Soy Flour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Foods Containing 20g Soy Flour
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Foods Containing 30g Soy Flour
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Foods Containing 10g Soy Flour
n=8 participants at risk
Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 20g Soy Flour
n=7 participants at risk
Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
Foods Containing 30g Soy Flour
n=7 participants at risk
Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
Food: Soy-fiber containing food
|
|---|---|---|---|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/8 • One week at each dose
|
14.3%
1/7 • Number of events 1 • One week at each dose
|
0.00%
0/7 • One week at each dose
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • One week at each dose
|
0.00%
0/7 • One week at each dose
|
14.3%
1/7 • Number of events 1 • One week at each dose
|
Additional Information
Dr. Candida Rebello
Pennington Biomedical Research Center
Phone: 2252882411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place