Effects of Brassica on Human Gut Lactobacilli (EBL)

• ClinicalTrials.gov Identifier: NCT02291328
• Recruitment Status: Completed
• First Posted: November 14, 2014
• Last Update Posted: May 4, 2015
• Sponsor: Quadram Institute Bioscience
• Collaborator: The Danish Council for Strategic Research
• Information provided by (Responsible Party): Quadram Institute Bioscience

Tracking Information

• First Submitted Date: November 11, 2014
• First Posted Date: November 14, 2014
• Last Update Posted Date: May 4, 2015
• Study Start Date: September 2014
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 17, 2014)

Lactobacilli in human faecal microbiota [ Time Frame: Two weeks ]

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.

Original Primary Outcome Measures (submitted: November 13, 2014)

Number of lactobacilli in human faecal microbiota [ Time Frame: Two weeks ]

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.

Current Secondary Outcome Measures (submitted: November 17, 2014)

• Human faecal microbial community composition [ Time Frame: Two weeks ]
  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.
• Human faecal bile acid profile [ Time Frame: Two weeks ]
  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.
• Faecal bacterial gene expression [ Time Frame: Two weeks ]
  To determine whether the consumption of a high and/or low Brassica vegetable diet causes a change in bacterial gene expression in the faeces.
• Urinary isothiocyanates (ITCs) excretion [ Time Frame: Two weeks ]
  To determine the extent of glucosinolate conversion to ITCs from Brassica vegetables, as measured by ITC excretion in the urine.

Original Secondary Outcome Measures (submitted: November 13, 2014)

• Changes to the human faecal microbial community as a whole [ Time Frame: Two weeks ]
  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.
• Human bile acid profile [ Time Frame: Two weeks ]
  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.
• Faecal bacterial gene expression [ Time Frame: Two weeks ]
  To determine whether the consumption of a high and/or low Brassica vegetable diet causes a change in bacterial gene expression in the faeces.
• Urinary isothiocyanates (ITCs) excretion [ Time Frame: Two weeks ]
  To determine the extent of glucosinolate conversion to ITCs from Brassica vegetables, as measured by ITC excretion in the urine.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Brassica on Human Gut Lactobacilli
• Official Title: A Human Intervention Trial Investigating the Effects of Brassica on Gut Lactobacilli
• 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 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.

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 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Human Gut Microbiota

Intervention

• Other: High 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.
• Other: Low Brassica
  Participants consume one portion of a Brassica vegetable (84g frozen broccoli, or 84g frozen cauliflower) each week for two weeks at their homes.

Study Arms

• Experimental: High Brassica
  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.
  Intervention: Other: High Brassica
• Experimental: Low 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.
  Intervention: Other: Low Brassica

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 13, 2014): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2015
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02291328
• Other Study ID Numbers: IFR04/2014
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Quadram Institute Bioscience
• Original Responsible Party: Same as current
• Current Study Sponsor: Quadram Institute Bioscience
• Original Study Sponsor: Same as current
• Collaborators: The Danish Council for Strategic Research

Investigators

• Principal Investigator: Richard Mithen, PhD; Quadram Institute Bioscience

• PRS Account: Quadram Institute Bioscience
• Verification Date: May 2015