Obesity Clinical Trial
— FIBREFOODSOfficial title:
The Impact of Dietary Fibres on Pancreatic Lipase Activity and Gastrointestinal Function
Verified date | November 2017 |
Source | Newcastle-upon-Tyne Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obesity is a wide reaching problem in the United Kingdom (UK). The most widely used obesity therapies are based around drugs that reduce dietary fat digestion, and thereby reduce uptake of calories from the diet. While such therapies have proved effective, patient compliance is low due to the unwanted gastrointestinal side effects of these drugs. Dietary fibre is generally classified as dietary material of plant origin that is indigestible to humans. Dietary fibre is in fact a wide range of different compounds that have varied effects on the human body. Initial findings from our laboratory suggest that types of fibre from seaweeds (alginates) can greatly reduce the rate that fat is digested in the laboratory. Our studies have identified which types of fibre are the most effective and our aim is to test whether this reduction in fat digestion is the same within the human body. This will be carried out by sampling the digestive fluid from 40 ileostomy patients over a five hour period following a test meal with and without dietary fibres. All study participants will be provided with test foods specially prepared containing the dietary fibres (e.g. in bread). We will collect data from the participants on what they have eaten and how hungry they feel.
Status | Completed |
Enrollment | 29 |
Est. completion date | March 7, 2013 |
Est. primary completion date | March 7, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Free-living - Male or female - Aged 18 years or above - Have previously gone through ileostomy surgery at least two years prior, and where the ileostomy procedure is classified as fully functional and stable - Generally healthy - Able to fulfill study time commitments and research burden within their usual lifestyle - In the case of the subset of participants who will give blood samples, that they are happy to provide blood samples Exclusion Criteria: - If the original reason for ileostomy (e.g. Crohn's disease, ulcerative colitis or cancer) is active during the study - Diagnosis of major health issues, either acute or longterm - Allergy, intolerance of dislike of any study foods |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Newcastle-upon-Tyne Hospitals NHS Trust | Biotechnology and Biological Sciences Research Council |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of fat excretion in ileostomy effluent | Measurement in grams of total lipid in ileal effluent every 30 minutes after test meal consumption | Every 30 minutes for up to 300 minutes after test meal consumption | |
Secondary | Assessment of general and gut wellbeing | Using VAS score from the well being questionnaire | Every 30 minutes for up to 300 minutes after test meal consumption | |
Secondary | Measurement of circulating triacylglycerol in blood | Measured in micro-molar of triacylglycerol (TAG) every 30 minutes after test meal consumption | Every 30 minutes for up to 300 minutes after test meal consumption |
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