NCT04499482

Safety and Tolerability of Soy Fiber

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 70 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety Issues
• Tolerance

Interventions

Type	Name	Description
OTHER	Food	Soy-fiber containing food

Timeline

• Start date: 2021-10-04
• Primary completion: 2022-04-14
• Completion: 2022-04-14
• First posted: 2020-08-05
• Last updated: 2023-05-18
• Results posted: 2023-05-18

Locations

1 site across 1 country: United States