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FBCx (Alpha-CD) Mechanism of Action Trial

NCT02999620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-08-11

No results posted yet for this study

Summary

To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as compared to placebo when consumed with a standardized radiolabeled fatty meal.

Conditions

  • Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

Alpha-cyclodextrin

Alpha-cyclodextrin (α-CD) is a soluble dietary fiber that has a history of use in foods and as a pharmaceutical excipient. Recently the ability of the fiber to bind to dietary fat has led to further investigation of the possible health benefits of dietary supplementation with this fiber.

DIETARY_SUPPLEMENT

Placebo

Identical looking placebo tablet to active (Alpha-cyclodextrin)

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • SFI Research

    lead INDUSTRY

Principal Investigators

  • Michael D Jensen, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-06-30
Completion
2017-07-31

Countries

  • Australia

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Entities

Companies

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 NCT02999620 on ClinicalTrials.gov