Cellodextrin Tolerability Study
CELLDEX
A Pilot Study to Assess the Tolerability of a Single, Ascending Dose of a Non-digestible Carbohydrate in Healthy Volunteers
2 other identifiers
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 3, 2015
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedJune 4, 2019
June 1, 2019
7 months
December 1, 2015
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastrointestinal discomfort
Gastrointestinal discomfort assessed by visual analogue scale up to 60 hours post consumption of cellodextrin
60 hours
Secondary Outcomes (7)
Diarrhoea
60 Hours
Subjective Appetite
60 Hours
Energy Intake
60 Hours
Change in whole blood glucose concentration
180 mins
Fecal microbiota
prior to exposure to the cellodextrin preparation
- +2 more secondary outcomes
Study Arms (4)
Level 1
EXPERIMENTAL10g of Cellodextrin
Level 2
EXPERIMENTAL20g of Cellodextrin
Level 3
EXPERIMENTAL30g of Cellodextrin
Level 4
EXPERIMENTAL50g of Cellodextrin
Interventions
Gastrointestinal tolerability of single ascending doses of Cellodextrins
Eligibility Criteria
You may qualify if:
- Age 18-40
- BMI 18-30 kg/m2
- Healthy
- Random Blood Glucose concentration below 7.8mmol/l
- Ability to give written informed consent
- English speaking
You may not qualify if:
- Age \<18 or \>40 years
- Any significant medical condition
- Random Blood Glucose concentration above 7.8mmol/l
- Use of regular medication (other than oral contraceptive pill)
- Use of herbal supplements
- History of Irritable Bowel Syndrome (IBS), food intolerances or any gastrointestinal disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
David Greenfield Human Physiology Unit
Nottingham, Notts, NG72UH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian A Macdonald, PhD
The University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 1, 2015
First Posted
December 3, 2015
Study Start
April 20, 2018
Primary Completion
November 30, 2018
Study Completion
April 30, 2019
Last Updated
June 4, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share