None listed
Conditions
Brief summary
Research has shown that the type of food consumed can influence the bacteria in the gastrointestinal tract (gut). It has also been shown that the bacteria in the gut can have an influence on human health. The presence of “unfavourable” bacteria within the gut has been linked to obesity, diabetes and some gastrointestinal disorders such as inflammatory bowel disease and irritable bowel syndrome. Researchers are therefore trying to determine what can be done to ensure the bacteria living in our gut are “favourable” to help optimise human health. A number of fibre supplements, known as prebiotics, have been shown to improve human health through their actions on “favourable” gut bacteria. Prebiotics are not digested by humans and therefore reach the large bowel where they are used by the gut bacteria as a source of energy. The amount of dietary fibre consumed between individuals varies considerably. We hypotheses that if someone is already consuming foods high in dietary fibre their gut bacteria will likely respond in a different way to a prebiotic supplement than the gut bacteria of an individual with a low intake of dietary fibre foods. The aim of the study is to determine what influence an individuals long term dietary fibre intake has on how their gut bacteria respond to a prebiotic supplement.
Interventions
The intervention is an inulin/fructo-oligosaccharide prebiotic. Participants will take 16g per day (2x8g sachets taken with breakfast and dinner) of the prebiotic powder mixed into food and hot beverages for a duration of 3 weeks. After a 3 week washout period participants will also take 16g per day (2x8g sachets taken with breakfast and dinner) of placebo powder mixed into food and hot beverages for a duration of 3 weeks The study is 10 weeks in duration as there is also a 1 week run-in period
The intervention is an inulin/fructo-oligosaccharide prebiotic. Participants will take 16g per day (2x8g sachets taken with breakfast and dinner) of the prebiotic powder mixed into food and hot beverages for a duration of 3 weeks. After a 3 week washout period participants will also take 16g per day (2x8g sachets taken with breakfast and dinner) of placebo powder mixed into food and hot beverages for a duration of 3 weeks The study is 10 weeks in duration as there is also a 1 week run-in period at the beginning of the study. Adherence to the intervention will be monitored using a daily diary and by asking the participants to return unused sachets.
Sponsors
Genelle Healey
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
The target population for recruitment are healthy male and female individuals between the age of 19 and 65 years with a BMI of between 18.5 and 30kg/m2. Individuals will need to have either a particularly low or high habitual dietary fibre intake to be considered eligible to participate in the study.
Exclusion criteria
* Aged <19 or >65 years * Taken antibiotics within the last 6 months * Taken laxatives, gastric motility medications, prebiotic or probiotic containing foods or supplements within the last month * Of poor health- cancer, gastrointestinal disorders (irritable bowel syndrome, inflammatory bowel disease, coeliac disease, constipation, diarrhoea, excessive bloating), autoimmune disorders, diabetes, heart disease, renal failure * BMI <18.5 or >30kg/m2 * Significant weight loss or weight gain (>5%) within the past year * Significant dietary change within the past year * Pregnant, breastfeeding or planning a pregnancy * Food intolerance which causes gastrointestinal symptoms (i.e. lactose intolerance, gluten sensitivity) * Smokers * High alcohol consumers If a potential participant is only ineligible to participate in the study because they are taking prebiotic or probiotic containing foods or supplements they can become eligible for inclusion in the study if they are willing to discontinue these foods or supplements for a month prior to starting the study and during the study.
Outcome results
None listed