Safety Issues, Tolerance
Conditions
Brief summary
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
Detailed description
The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects will incorporate the foods containing soy into their usual diet for one week. The tolerability to each dose will be evaluated and fecal short chain fatty acids will be measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and express willingness to consume the study foods will be enrolled.
Interventions
OTHERFood
Soy-fiber containing food
Sponsors
National Institute on Aging (NIA)
Pennington Biomedical Research Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Dose escalating cross over trial
Eligibility
Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult (70 - 85 years). * Body mass index between 30 and 40 kg/m2. * No evidence of diabetes (fasting blood sugar \<126 mg/dL). * No evidence of dementia (MMSE score \> 25). * No evidence of depression. (Geriatric Depression Scale-15 \[GDS-15\] \< 6. * Are weight stable (\< 3 kg weight change in the past three months).
Exclusion criteria
* Have type 1 or type 2 diabetes currently being treated by medication. * Report clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease. * Are being treated with medications that have a significant effect on insulin resistance, obesity, and metabolic rate, or medications that significantly increase body weight such as antidepressants, second-generation antipsychotics, systemic glucocorticoids, and adrenergic blockers or stimulators (unless the dose and body weight have been stable for six months). * Have serum triglyceride concentrations \> 400 mg/dl. * Clinically significant abnormal laboratory markers (as determined by the medical investigator). * Subjects with anticipated surgery during the study period. * Subjects with a reported history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study. * Subjects who are current smokers or have smoked within the previous three months. Smoking is not permitted during the study. * Subjects who are unable to provide a baseline blood or fecal sample or if they have any condition that impedes testing of the study hypothesis or makes it unsafe to consume the food being tested in the study (determined by the investigative team). * Women on hormone replacement therapy unless weight has been stable over the last six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 g Soy-related Stool Consistency | One week | 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. |
| 30 g Soy-related Stool Frequency | One week | 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 |
| 10 Soy-related Stool Consistency | One week | 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. |
| 20 g Soy-related Stool Consistency | One week | 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. |
| Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy | One week at each dose | 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 |
| 10 g Soy-related Gastrointestinal Symptoms | One week | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. |
| 20 g Soy-related Gastrointestinal Symptoms | One week | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. |
| 30 g Soy-related Gastrointestinal Symptoms | One week | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. |
| 10 g Soy-related Stool Frequency | One week | 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 |
| 20 g Soy-related Stool Frequency | One week | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 20 g Soy Intake Effect on Fecal Short Chain Fatty Acids | One week | Measurement of fecal short chain fatty acids in response to intake of soy |
| 30 g Soy Intake Effect on Fecal Short Chain Fatty Acids | One week | Measurement of fecal short chain fatty acids in response to intake of soy |
| 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids | One week | Measurement of fecal short chain fatty acids in response to intake of soy |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Study 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 | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 73 Years STANDARD_DEVIATION 2 |
| Body Mass Index | 34 kg/m^2 STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 1 / 7 | 1 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 | 0 / 7 |
Outcome results
Primary
10 g Soy-related Gastrointestinal Symptoms
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Time frame: One week
Population: One subject dropped from the study at Day 3 of week one and was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Foods Containing 10 g Soy Flour | 10 g Soy-related Gastrointestinal Symptoms | Bloating | Mild | 1 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Gastrointestinal Symptoms | Bloating | None | 6 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Gastrointestinal Symptoms | Abdominal Rumbling | Mild | 2 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Gastrointestinal Symptoms | Abdominal Rumbling | None | 5 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Gastrointestinal Symptoms | Flatulence | Mild | 2 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Gastrointestinal Symptoms | Flatulence | None | 5 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Gastrointestinal Symptoms | Abdominal Pain | Mild | 0 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Gastrointestinal Symptoms | Abdominal Pain | None | 7 Participants |
Primary
10 g Soy-related Stool Frequency
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
Time frame: One week
Population: One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 10 g Soy-related Stool Frequency | 1-2 | 2 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Stool Frequency | 3-4 | 4 Participants |
| Foods Containing 10 g Soy Flour | 10 g Soy-related Stool Frequency | 5-6 | 1 Participants |
Primary
10 Soy-related Stool Consistency
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.
Time frame: One week
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 10 Soy-related Stool Consistency | 3, Normal (Like sausage but with cracks) | 2 Participants |
| Foods Containing 10 g Soy Flour | 10 Soy-related Stool Consistency | 4, Normal (Like sausage, smooth and soft | 3 Participants |
| Foods Containing 10 g Soy Flour | 10 Soy-related Stool Consistency | 5, Normal (Soft blobs with clear cut edges) | 2 Participants |
| Foods Containing 10 g Soy Flour | 10 Soy-related Stool Consistency | 1, Abnormal(Separate hard lumps) | 0 Participants |
| Foods Containing 10 g Soy Flour | 10 Soy-related Stool Consistency | 2, Abnormal (Sausage-shaped but lumpy) | 0 Participants |
| Foods Containing 10 g Soy Flour | 10 Soy-related Stool Consistency | 6, Abnormal (Fluffy pieces with ragged edges) | 0 Participants |
| Foods Containing 10 g Soy Flour | 10 Soy-related Stool Consistency | 7, Abnormal (Watery) | 0 Participants |
Primary
20 g Soy-related Gastrointestinal Symptoms
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Time frame: One week
Population: One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Foods Containing 10 g Soy Flour | 20 g Soy-related Gastrointestinal Symptoms | Bloating | Mild | 0 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Gastrointestinal Symptoms | Bloating | None | 7 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Gastrointestinal Symptoms | Abdominal Rumbling | Mild | 1 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Gastrointestinal Symptoms | Abdominal Rumbling | None | 6 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Gastrointestinal Symptoms | Flatulence | Mild | 5 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Gastrointestinal Symptoms | Flatulence | None | 2 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Gastrointestinal Symptoms | Abdominal pain | Mild | 0 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Gastrointestinal Symptoms | Abdominal pain | None | 7 Participants |
Primary
20 g Soy-related Stool Consistency
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.
Time frame: One week
Population: One subject was dropped from the study on Day 3 of week 1 and was not included in the analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Consistency | 3, Normal (Like a sausage, but with cracks) | 0 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Consistency | 4, Normal (Like sausage, smooth and soft) | 5 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Consistency | 5, Normal (Soft blobs with clear-cut edges) | 2 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Consistency | 1, Abnormal (Separate hard lumps) | 0 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Consistency | 2, Abnormal (Sausage-shaped but lumpy) | 0 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Consistency | 6, Abnormal (Fluffy pieces with ragged edges) | 0 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Consistency | 7, Abnormal (Watery) | 0 Participants |
Primary
20 g Soy-related Stool Frequency
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
Time frame: One week
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Frequency | 1-2 | 1 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Frequency | 3-4 | 5 Participants |
| Foods Containing 10 g Soy Flour | 20 g Soy-related Stool Frequency | 5-6 | 1 Participants |
Primary
30 g Soy-related Gastrointestinal Symptoms
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Time frame: One week
Population: One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Foods Containing 10 g Soy Flour | 30 g Soy-related Gastrointestinal Symptoms | Bloating | Mild | 1 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Gastrointestinal Symptoms | Bloating | None | 6 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Gastrointestinal Symptoms | Abdominal Rumbling | Mild | 1 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Gastrointestinal Symptoms | Abdominal Rumbling | None | 6 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Gastrointestinal Symptoms | Flatulence | Mild | 5 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Gastrointestinal Symptoms | Flatulence | None | 2 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Gastrointestinal Symptoms | Abdominal Pain | Mild | 1 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Gastrointestinal Symptoms | Abdominal Pain | None | 6 Participants |
Primary
30 g Soy-related Stool Consistency
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.
Time frame: One week
Population: One subject was dropped from the study at Day 3 and was not included in the analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Consistency | 3, Normal (Like a sausage but with cracks) | 0 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Consistency | 4, Normal (Like a sausage, smooth and soft) | 2 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Consistency | 5, Normal (Soft blobs with clear-cut edges) | 4 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Consistency | 1, Abnormal (Separate hard lumps) | 1 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Consistency | 2, Abnormal (Sausage-shaped but lumpy) | 0 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Consistency | 6, Abnormal (Fluffy pieces with ragged edges) | 0 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Consistency | 7, Abnormal (Watery) | 0 Participants |
Primary
30 g Soy-related Stool Frequency
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
Time frame: One week
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Frequency | 1-2 | 1 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Frequency | 3-4 | 3 Participants |
| Foods Containing 10 g Soy Flour | 30 g Soy-related Stool Frequency | 5-6 | 3 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy
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
Time frame: One week at each dose
Population: One subject dropped from the study at Day 3 of week one and was not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foods Containing 10 g Soy Flour | Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy | 0 Participants |
| Foods Containing 20 g Soy Flour | Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy | 1 Participants |
| Foods Containing 30 g Soy Flour | Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy | 1 Participants |
Secondary
10 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Measurement of fecal short chain fatty acids in response to intake of soy
Time frame: One week
Population: One subject was dropped from the study at Day 3 and was excluded from the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 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
20 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Measurement of fecal short chain fatty acids in response to intake of soy
Time frame: One week
Population: One subject was dropped from the study at Day 3 and was excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 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
30 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Measurement of fecal short chain fatty acids in response to intake of soy
Time frame: One week
Population: One subject was dropped from the study at Day 3 and was excluded from the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foods Containing 10 g Soy Flour | 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 |