Safety and Tolerability of Soy Fiber
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Safety Issues
- Tolerance
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Dose escalating cross over trialMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 70 years and 85 years
- Gender
- Both males and females
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. ...
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.
Tracking Information
- NCT #
- NCT04499482
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Principal Investigator: Candida Rebello, Ph.D. Pennington Biomedical Research Center
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