Safety and Tolerability of Soy Fiber

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Tolerability of Soy Fiber in the Elderly: A Dose Escalation Study

Conditions
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Safety Issues, Tolerance

Intervention / Treatment
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* Other: Food


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Dose escalating cross over trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foods containing 10 g soy flour<br>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. | Other: Food<br>* Soy-fiber containing food<br>|
| Experimental: Foods containing 20 g soy flour<br>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. | Other: Food<br>* Soy-fiber containing food<br>|
| Experimental: Foods containing 30 g soy flour<br>Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week. | Other: Food<br>* Soy-fiber containing food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | One week | 
| 20 g Soy-related Gastrointestinal Symptoms | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. | One week | 
| 30 g Soy-related Gastrointestinal Symptoms | Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe. | 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 | 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 | 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 | 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. | 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. | 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. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids | Measurement of fecal short chain fatty acids in response to intake of soy | 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 | 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 | One week |