Hypercholesterolemia Clinical Trial
— FFSOfficial title:
Effect of Wheat Bran Extract Containing Arabinoxylan Oligosaccharides, on the Gut Microbiota Composition and Well-being in Healthy Aging Subjects PhD Project: New Targeted Prebiotic Approaches for Maintaining Human Health
Verified date | September 2016 |
Source | University of Aberdeen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a placebo controlled, cross-over, randomized, double blinded study. The intervention
food products will be taken as diet prebiotic supplements: 1. Wheat Bran Extract rich in
arabinoxylan oligosaccharides : 15g/d (up to 10 g total additional dietary fibre per day).
2. Placebo product maltodextrin:equal amounts of a digestible carbohydrate.
Primary endpoints are faecal microbiota analysis and faecal metabolite analysis
(particularly, short chain fatty acid). Secondary endpoint is serum cholesterol, glucose,
HDL and bowel function, gastrointestinal tolerance, quality of life and food frequency (by
the use of questionnaires).
Status | Completed |
Enrollment | 21 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Males and females aged 60 years and above - Body mass index 20-32 kg/m2 Exclusion Criteria: - Fructose intolerance/ or any of the ingredients in the prebiotic mix - On prescription antibiotics within the past 3 months - Bowel disorder - Vegetarian or vegan - Eating disorders and food intolerances (restricted eating) - Wheat and gluten allergy, coeliac disease - Alcohol and/or other substance abuse - Regular intake of prebiotic or probiotic supplements - Smoking - Psychiatric disorders resulting in perceived inability to give informed consent (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders) - Lipid/Cholesterol lowering medication (as cholesterol is one of the endpoints of the study) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Rowett Institute of Nutrition and Health, University of Aberdeen | Aberdeen |
Lead Sponsor | Collaborator |
---|---|
University of Aberdeen | Cargill |
United Kingdom,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the gut microbiota metabolites | Samples will be used for metabolite analysis using short chain fatty acid analysis. | Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days | |
Secondary | Changes in the gut microbiota | Sample will be used for microbiota analysis using molecular methods such as high-throughput sequencing and qPCR. | Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days | |
Secondary | Changes in blood glucose | Blood samples will be measured for glucose using the Cholestech method. | Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days | |
Secondary | Changes in blood HDL | Blood samples will be measured for HDL using the Cholestech method. | Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days | |
Secondary | Changes in blood LDL | Blood samples will be measured for LDL using the Cholestech method. | Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days | |
Secondary | Changes in blood triglycerides | Blood samples will be measured for triglycerides using the Cholestech method. | Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days | |
Secondary | Changes in blood cholesterol | Blood samples will be measured for cholesterol using the Cholestech method. | Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days | |
Secondary | Gastrointestinal tolerance | A daily questionnaire will be asked on: Nausea Bloating Flatulence Cramps Bowel movements Stool appearance |
This is assessed via a daily questionnaire throughout the whole study period of 35 days. | |
Secondary | Volunteer's habitual diet food intake | A Food Frequency Questionnaire (FFQ) will be completed at the start and the end of the study. http://www.foodfrequency.org/ | This is assessed via questionnaires given at the start and end of the study (day 0 and day 35) | |
Secondary | General health and well-being (This is assessed via questionnaires at the end of the study) | A health survey will be completed at the end of the study on activities, physical and emotional well-being. | day 35 | |
Secondary | Changes in faecal inflammatory markers | Faecal calprotectin will be measured using ELISA method. | Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days |
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