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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
8
Soy-fiber containing food
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
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
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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: One week
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
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
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
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
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
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