Safety and Tolerability of Soy Fiber

Not Applicable

Completed

Conditions: Safety Issues
Tolerance

Interventions: Other: Food

Registration Number: NCT04499482

Lead Sponsor: Pennington Biomedical Research Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Foods containing 20 g soy flour	Food	Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period.
Foods containing 10 g soy flour	Food	Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period.
Foods containing 30 g soy flour	Food	Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.

Primary Outcome Measures

Name	Time	Method
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 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 Gastrointestinal Symptoms	One week	Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
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.
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.
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.
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
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