Obesity Clinical Trial
— CELLDEXOfficial title:
A Pilot Study to Assess the Tolerability of a Single, Ascending Dose of a Non-digestible Carbohydrate in Healthy Volunteers
Verified date | June 2019 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | April 30, 2019 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | David Greenfield Human Physiology Unit | Nottingham | Notts |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | Biotechnology and Biological Sciences Research Council |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastrointestinal discomfort | Gastrointestinal discomfort assessed by visual analogue scale up to 60 hours post consumption of cellodextrin | 60 hours | |
Secondary | Diarrhoea | Bristol Stool Score used to assess change in bowel habit up to 60 hours after cellodextrin consumption | 60 Hours | |
Secondary | Subjective Appetite | Subjective appetite assessed periodically up to 60 hours after cellodextrin consumption using visual analogue scales | 60 Hours | |
Secondary | Energy Intake | Dietary energy intake assessed by diet diaries | 60 Hours | |
Secondary | Change in whole blood glucose concentration | blood glucose response to the milkshake drink | 180 mins | |
Secondary | Fecal microbiota | assessment of the bacterial population in fecal samples | prior to exposure to the cellodextrin preparation | |
Secondary | fecal microbiota | change in bacterial population as a result of exposure to cellodextrins | 48hrs | |
Secondary | Fluid balance | fluid balance assessment for 24hrs after cellodextrin consumption | 24hrs |
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