Effects of Brassica on Human Gut Lactobacilli

NCT02291328 | Completed

• 1 other identifier: IFR04/2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  Two weeks

Secondary Outcomes (4)

• Human faecal microbial community composition

  Two weeks

• Human faecal bile acid profile

  Two weeks

• Faecal bacterial gene expression

  Two weeks

• Urinary isothiocyanates (ITCs) excretion

  Two weeks

Study Arms (2)

High Brassica

EXPERIMENTAL

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

Low Brassica

EXPERIMENTAL

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

Interventions

High Brassica OTHER

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.

High Brassica

Low Brassica OTHER

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

Low Brassica

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• The Danish Council for Strategic Research: collaborator

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Study Officials

• Richard Mithen, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 4, 2015

Record last verified: 2015-05

Locations

GB (1)