Human Gut Microbiota Clinical Trial
Official title:
A Human Intervention Trial Investigating the Effects of Brassica on Gut Lactobacilli
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.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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