Status:
COMPLETED
Effects of Brassica on Human Gut Lactobacilli
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
The Danish Council for Strategic Research
Conditions:
Human Gut Microbiota
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Brassica vegetables are an important part of the investigators normal diet and are associated with a reduced risk of many chronic diseases. The protective effect may be as a result of the hydrolytic p...
Detailed Description
The study is a randomised human dietary intervention two-phase cross-over study and will require the participants to consume both a low and a high Brassica vegetable diet. In this study, male and fema...
Eligibility Criteria
Inclusion
- Men and women aged between 18 and 50.
- Smokers and non-smokers.
- Those with a body mass index (BMI) between 19.5 and 30 kg/m2.
- Those that live within a 40 mile radius of Norwich.
Exclusion
- Women who are or have been pregnant within the last 12 months, or are lactating and/or breast feeding.
- Those currently suffering from, or have ever suffered from, any diagnosed gastrointestinal disease, gastrointestinal disorders including regular diarrhoea and constipation (excluding hiatus hernia unless symptomatic) and/or have undergone gastrointestinal surgery, or the study intervention/procedure is contraindicated.
- Have been diagnosed with any long-term medical condition that may affect the study outcome (e.g. diabetes, haemophilia, cardiovascular disease, glaucoma, anaemia). These will be assessed on an individual basis.
- Those diagnosed with a long-term medical condition requiring medication that may affect the study outcome.
- Those regularly taking self-prescribed over the counter medications for digestive/gastrointestinal conditions.
- Those on long-term antibiotic therapy. Those who have been on a course of antibiotics are able to participate in/continue on the study once 4 weeks has elapsed from the end of the course of antibiotics. This will be assessed on an individual basis.
- Those regularly taking laxatives (once a month or more).
- Those intermittently using pre \&/or probiotics unless willing to abstain for 1 month prior to and during study period. (If used regularly (3+ times a week, and for more than one month) and will continue throughout study period then do not exclude).
- Those on a diet programme or those who plan to start a diet programme during the study that may affect the study outcome (e.g. the 5:2 fasting diet) unless willing to abstain for 1 month prior to and during study period. These will be assessed on an individual basis.
- Those taking dietary supplements or herbal remedies (including those derived from Brassica plants) which may affect the study outcome - unless the participant is willing to discontinue taking them for 1 month prior to and during study period. Please note that some supplements may not affect the study and this will be assessed on an individual basis.
- Regular/recent (within 3 months) use of colonic irrigation or other bowel cleansing techniques.
- Recently returned to the United Kingdom (UK) following a period abroad, and who have suffered gastric symptoms during the period abroad or on return to the UK. These will be assessed on an individual basis.
- Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/materials. Sampling of certain biological samples, such as saliva, may not affect the study and this will be assessed on an individual basis.
- Those who record blood in their stools or have two or more episodes of type 1, 2, or 7 stools during the study.
- Any person related to or living with any member of the study team.
- Those who are unwilling to provide the contact details of their general practitioners (GPs).
- Those who are unable to provide written informed consent.
- Those who are not suitable to take part in this study because of their eligibility screening results.
- Those who do not have access to a freezer.
- Those who regularly consume more than 15 units of alcohol (women) or 22 units of alcohol (men) a week.
- Those who are allergic to any of the foods/ingredients within the foods supplied.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02291328
Start Date
September 1 2014
End Date
April 1 2015
Last Update
May 4 2015
Active Locations (1)
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1
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA