BIOMET - 7 STUDY
BIOMET - 7: The effects of the bile acid supplement, 7-keto lithocholic acid, on human gut microbiota and risk factors for disease.
Purpose of the study
In age-related diseases involving heart, liver, brain, and immunity, it is becoming apparent that a dysregulated gut may be key to understanding and effecting beneficial change. This study aims to assess the beneficial effects of a bile acid supplement in adults, by promoting a healthy microbiome (as measured by a balance between helpful and potentially harmful bacteria) and leading to improved health. In the course of this study, key biomarkers (for example, changes in microbial composition, blood glucose, cholesterol, and inflammatory markers) will be tracked to directly assess the benefits of a bile acid supplement on the gut microbiome, which may help reduce the risk of developing disease.
Who can take part in this study?
The study will recruit 40 participants between the ages of 18 and 65 years. Suitable volunteers should:
- Have a body mass index of between 18.5 and 29.9 kg/m2.
- Be non-smokers who drink no more than 14 units of alcohol (i.e. not more than 6 pints of beer or 6 small glasses of wine) per week.
- Not be undertaking regular vigorous exercise or fitness training on more than 3 occasions per week.
Exclusion criteria
Participants who will not be able to take part in the study include those:
- with a pacemaker.
- diagnosed with diabetes, heart disease (previous stroke or heart attack), kidney, bowel or liver diseases, cancer or hormone abnormalities or at risk of an allergic reaction.
- taking certain types of medication (e.g. for high blood pressure, high blood fats, inflammatory conditions and depression), or dietary supplements (e.g. probiotics, prebiotics and natural laxatives), antibiotics in the last 3 months.
- who are actively trying to lose or who have lost more than 3 kg of weight in the last 6 months.
Volunteers who are participating in another intervention study will be also excluded.
What will taking part in the study involve?
One initial screening visit and four subsequent study visits, if you are eligible to take part in the study. A small blood sample will be taken during the screening visit and your weight, height and blood pressure will be measured. 4 study visits will follow, at four weeks intervals over a period of 16 weeks. You will be required to provide the following, throughout the course of the study, at each study visit: 4 x stool samples and 4 x blood samples. Stool samples will be collected in at-home kits, which will be explained and provided to you at your screening visit. For each visit, you will be asked to arrive in an unfed state (fasted, not eating or drinking anything but water from 8 pm the night before).
Screening visit
You will be invited to come for an initial screening visit at the Hugh Sinclair Unit of Human Nutrition in the Department of Food & Nutritional Sciences (University of Reading). The screening visit should take no more than 45 minutes.
Preparation for study visits
Main study visits
The four study visits will be conducted at 4 weeks interval over a total of 16 weeks and each visit will last for approximately 45 minutes. For each study visit, upon arrival at the Hugh Sinclair Unit of Human Nutrition, your weight, waist circumference, blood pressure and body composition will be measured. During each study visit, a blood sample will be taken.
During your first study visit, you will receive the supplement (bile acid or placebo), to be taken daily after breakfast, for a period of 4 weeks (28 days), after which time you will be asked to attend your second study visit. You will continue to take the daily supplement until your third study visit which will then take place after a period of 8 weeks (56 days). Following your third study visit, you will then have a period of 4 weeks (28 days) where you will not be taking the daily supplement (called a ‘wash out’ period), after which time you will attend for your fourth and final study visit.