Safety and Tolerability of Soy Fiber

NCT04499482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-05-18

Study results available
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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.

Conditions

  • Safety Issues
  • Tolerance

Interventions

OTHER

Food

Soy-fiber containing food

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Candida Rebello, Ph.D. · Pennington Biomedical Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
70 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2022-04-14
Completion
2022-04-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04499482 on ClinicalTrials.gov