An interventional study of High Brassica and Low Brassica in Human Gut Microbiota, sponsored by Quadram Institute Bioscience. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-04.
Sponsored by Quadram Institute Bioscience · Not applicable, Interventional, and Basic science
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 products of compounds contained within these vegetables, called glucosinolates. There is evidence that consumption of Brassica vegetables may cause compositional changes to the investigators gut microbiota. The aim of this study is to see whether a diet rich in Brassica alters the human gut microbiota composition, and specifically whether it causes an increase in the number of the beneficial bacteria known as lactobacilli.
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 female participants aged between 18 and 50 years will be recruited until 10 complete the study. For the low Brassica diet test phase, the participants will be provided with one 84g portion of frozen broccoli and one 84g portion of frozen cauliflower, to be consumed across a period of two weeks. The participants will be asked to consume one of these portions of Brassica (either broccoli or cauliflower) in week one, and then consume the remaining portion of Brassica in week two, with a minimum of 5 days between consuming the two portions. When on the high Brassica diet test phase, the participants will be provided with six 84g portions of frozen broccoli, six 84g portions of frozen cauliflower, and six 300g portions of frozen broccoli and sweet potato soups (each with a broccoli content of 84g), to be consumed across a period of two weeks. The participants will be asked to consume three portions of broccoli, three portions of cauliflower, and three portions of the broccoli and sweet potato soups each week for two weeks, consuming a minimum of one portion per day. The Brassica diet test phases will be separated by a washout period, which will be a minimum of 2 weeks.
The participants will be asked to restrict their diet of Brassica vegetables and ITC-containing foods for a period which includes 2 weeks prior to test phases 1 and 2, as well as during the full 2 weeks of each test phase. The participants will be asked to provide faecal samples, urine samples, complete food diaries and stool charts at various stages throughout the intervention. Participants will be asked to complete a food diary, recording the consumption of all fruits and vegetables, for a consecutive seven day period, during each of the two test phases (test phases 1 and 2), and for the entire seven days of the last week of the study when consuming their habitual diet. Participants will also need to be willing to complete stool charts noting the frequency and consistency of their bowel movements.
Quadram Institute Bioscience is the lead sponsor of 44 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Participants will be asked to consume 3x 84g portions of frozen broccoli, 3x 84g portions of frozen cauliflower, and 3x 300g portions of frozen broccoli and sweet potato soups a week for a total of 2 weeks.
Other: High Brassica
Participants will be asked to consume 1x 84g portion of either frozen broccoli or frozen cauliflower in week one, and the remaining 84g portion of Brassica in week two.
Other: Low Brassica
Participants consume a minimum of one portion of a Brassica food (84g frozen broccoli, 84g frozen cauliflower, or 300g frozen broccoli and sweet potato soup) each day for 14 consecutive days at their homes.
Participants consume one portion of a Brassica vegetable (84g frozen broccoli, or 84g frozen cauliflower) each week for two weeks at their homes.
Lactobacilli in human faecal microbiota
To investigate whether eating a diet rich in Brassica vegetables for two weeks will cause an increase in human gut lactobacilli, compared to the number of lactobacilli present in the participants' normal gut microbiota.
Time frame: Two weeks
Human faecal microbial community composition
To ascertain whether eating a diet rich in Brassica vegetables modulates the gut microbial community as a whole, as compared to the consumption of a low Brassica diet, and the participants' normal gut microbiota.
Time frame: Two weeks
Human faecal bile acid profile
To determine whether the consumption of a high and/or low Brassica vegetable diet causes a change in short chain fatty acids and bile acids in the faeces.
Time frame: Two weeks
Faecal bacterial gene expression
To determine whether the consumption of a high and/or low Brassica vegetable diet causes a change in bacterial gene expression in the faeces.
Time frame: Two weeks
Urinary isothiocyanates (ITCs) excretion
To determine the extent of glucosinolate conversion to ITCs from Brassica vegetables, as measured by ITC excretion in the urine.
Time frame: Two weeks
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Quadram Institute Bioscience