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Cellodextrin Tolerability Study

NCT02621086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-06-04

No results posted yet for this study

Summary

This is an initial pilot study to assess and investigate if any adverse symptoms occur (and also the severity of any symptoms) after consuming a food-grade Cellodextrin preparation. Volunteers will attend a short (around 30mins) medical screening visit, to make sure they are suitable to take part in the study. They will then attend 4 study visits (separated by at least a week) for around 9.5 hours each time. During the study visits 10, 20, 30, or 50g of Cellodextrin will be given as a single oral dose, in a milkshake drink, and any symptoms experienced will then be monitored via questionnaires during the study day and for the next 60 hrs, dietary intake will also be measured over this time.

Conditions

Interventions

DIETARY_SUPPLEMENT

Cellodextrin

Gastrointestinal tolerability of single ascending doses of Cellodextrins

Sponsors & Collaborators

  • Biotechnology and Biological Sciences Research Council

    collaborator OTHER

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Ian A Macdonald, PhD · The University of Nottingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2018-11-30
Completion
2019-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT02621086 on ClinicalTrials.gov