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Effect of Phytin on Human Gut Microbiome (EPoM) (EPoM)

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ClinicalTrials.gov Identifier: NCT03917693
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Quadram Institute Bioscience

Brief Summary:

Within many plants, such as seeds, nuts and cereals, there is a compound called phytic acid. Phytic acid has many beneficial properties, including producing molecules which slows down the damage that can be caused to other molecules within the body. Phytic acid has also been known to help in the treatment of cancer. Phytic acid binds iron very strongly. Iron is an extremely important nutrient not only for humans, but also for a lot of bacteria. In humans, iron is absorbed in the small intestine. Unfortunately, iron does not get absorbed very well and so a lot of it travels into the large intestine. The large intestine contains trillions of bacteria and a lot of these bacteria use iron as food. However, not all bacteria in the large intestine are 'good bacteria'. Some bacteria, such as Enterobacteria, can be harmful to people's health. For this reason, if iron is kept away from these 'bad bacteria' through the binding of phytic acid and iron, it could prove to be beneficial to human health. In general, our gut contains trillions of bacteria, many of which help us to unlock extra nutrients from the food we eat. Some bacteria, such as Bifidobacteria, are often referred to as 'good bacteria' and are added to foods such as yoghurts. Many 'good bacteria' are able to survive without iron and this makes it even more important to make sure the 'bad bacteria' have limited access to iron. Otherwise, we could find ourselves with a large intestine that has more harmful bacteria than beneficial bacteria.

In this study, we will ask participants to consume either the test capsule, which contains phytin (a salt form of phytic acid), or a control capsule, which contains a powder resembling phytin but is actually an inactive substance. We are interested in whether consuming these capsules will decrease Enterobacteria (one of the 'bad bacteria' in the large intestine).


Condition or disease Intervention/treatment Phase
Diet Modification Dietary Supplement: Phytin, rice extract Other: MCC, placebo Not Applicable

Detailed Description:

The study will take place at the Clinical Research Facility (CRF) at the Quadram Institute in Norwich, with participants attending the QI CRF for screening and to collect the capsules for consumption (capsules will be randomly allocated, containing either phytin or placebo (microcrystalline cellulose). The participants will be recruited from within a 40-mile radius of Norwich and this is clearly stated in the PIS. In this study, male and female participants aged between 18 and 50 years will be recruited until 14 participants complete the study. The participants will consume the randomly allocated capsules (containing either phytin or placebo), and collect their faecal samples at their home.

The purpose of this study is to ascertain whether the delivery of phytin to the colon will cause a decrease in the proportions of human gut enterobacteriaceae, and a potential concomitant increase in the proportion of human gut bifidobacteriaceae, through chelation of iron.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

This process will be carried out by a QIB scientist who is not part of the study team.

Wendy Hollands (QIB FIH scientist) will be responsible for this process, and therefore ensures the trial remains blinded to the study participants, Chief Investigators and study scientists/advisors.

Primary Purpose: Basic Science
Official Title: A Human Intervention Trial Investigating the Effects of Phytin on the Human Gut Microbiome
Estimated Study Start Date : April 29, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Active Comparator: Phytin capsules
2.4 g phytin to be consumed daily for a period of 2 weeks. Participants will consume 2 test capsules containing phytin, 3 times a day with a meal for a period of 2 weeks.
Dietary Supplement: Phytin, rice extract
Consumption of a rice extract, called phytin for a period of 2 weeks

Placebo Comparator: Microcrystalline cellulose (MCC) capsules
2.4 g MCC to be consumed daily for a period of 2 weeks. Participants will consume 2 placebo capsules, each containing microcrystalline cellulose, 3 times a day with a meal for a period of 2 weeks.
Other: MCC, placebo
Consumption of MCC, a placebo, for a period of 2 week




Primary Outcome Measures :
  1. Relative abundance of Enterobacteriaceae [ Time Frame: 4 months ]
    To investigate whether consuming phytin for two weeks will cause a proportional decrease in human gut Enterobacteriaceae compared to the number of Enterobacteriaceae present in the participants' gut microbiome after consuming the control capsule.


Secondary Outcome Measures :
  1. Relative abundance of Bifidobacteriaceae [ Time Frame: 4 months ]
    To investigate whether the delivery of phytin to the colon for a period of two weeks will be associated with an increase in human gut bifidobacteriaceae through the chelation of iron, compared to the number of bifidobacteriaceae present in the participants' baseline gut microbiota, as determined by faecal bacteria phylogenic analysis

  2. Gut microbial composition [ Time Frame: 4 months ]
    To ascertain whether consuming phytin modulates the gut microbial community as a whole, as compared to the consumption of a placebo capsule

  3. Short chain fatty acids [ Time Frame: 4 months ]
    To determine whether the consumption of phytin causes a change in short chain fatty acid levels in the faeces, via changes in the gut microbiome function

  4. Iron concentrations [ Time Frame: 4 months ]
    To determine whether the consumption of phytin causes a change in the available iron present in the faeces

  5. Phytin degradation [ Time Frame: 4 months ]
    To ascertain the extent of phytin degradation that takes place in the colon based on the known concentration of phytin administered via the capsule

  6. Gut inflammation [ Time Frame: 4 months ]
    To determine levels of calprotectin as a marker of gut inflammation

  7. Systemic inflammation [ Time Frame: 4 months ]
    To determine levels of C-Reactive Protein (CRP) as a marker of systemic inflammation

  8. Release of capsule [ Time Frame: 4 months ]
    To measure serum ferritin levels as a marker of the time of capsule release



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged between 18 and 50
  • Non-smokers (e-cigarette/vape users are able to participate)
  • Those with a body mass index (BMI) between 19.5 and 30 kg/m^2
  • Those that live within a 40-mile radius of Norwich

Exclusion Criteria:

  • results of our screening test indicate you are not suitable to take part in this study
  • are pregnant, have been pregnant in the last year or are lactating and/or breast feeding
  • are 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. cancer, diabetes, haemophilia, cardiovascular disease, glaucoma, anaemia). These will be assessed on an individual basis
  • have been diagnosed with any long-term medical condition requiring medication that may affect the study outcome
  • regularly taking over the counter medications for digestive/gastrointestinal conditions
  • are on long-term antibiotic therapy. You may be able to participate if 4 weeks has passed from the end of a course of antibiotics (this will be assessed on an individual basis)
  • regularly take laxatives (once a month or more)
  • take certain dietary supplements or herbal remedies and are unwilling to stop taking them for one month prior to and during study period. This will be assessed on an individual basis
  • take pre- or pro-biotic drinks &/or yoghurts on an occasional basis, unless willing to abstain for one month prior to and during the study period. (if you regularly take pre-&/or pro biotics (3+ times a week, and for more than one month) and will continue throughout the study then you will not be excluded)
  • are on or plan to start a diet programme that may affect the study outcome (e.g. 5:2 fasting diet) unless willing to abstain for 1 month prior to and during study period. This will be assessed on an individual basis
  • recently returned to the 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
  • regular/recent (within 3 months) use of colonic irrigation or other bowel cleansing techniques
  • are involved in another research project that includes dietary intervention or involving blood sampling
  • record blood in your stools or have two or more episodes of constipation or diarrhoea (type 1, 2, or 7 stools) during the study
  • are unwilling to provide GPs contact details
  • are unable to provide written informed consent.
  • regularly consume more than 15 units (women) or 22 units (men) of alcohol a week
  • Regularly taking iron supplements
  • Those unable to swallow capsules
  • Those with abnormal blood pressure measurements (160/100 will be regarded as an exclusion value)
  • Are related to someone in the study (e.g. spouse, partner, immediate family member)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917693


Contacts
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Contact: Bhavika Parmanand +4401603255021 Bhavika.Parmanand@quadram.ac.uk
Contact: Lee Kellingray, Phd +4401603255070 lee.kellingray@quadram.ac.uk

Locations
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United Kingdom
Quadram Institute Bioscience
Norwich, Norfolk, United Kingdom, NR4 7UA
QI NNUHFT Clinical Research Facility Not yet recruiting
Norwich, Norfolk, United Kingdom, NR4 7UQ
Contact: Melanie Pascale, PhD    +4401603 647327    melanie.pascale@nnuh.nhs.uk   
Sponsors and Collaborators
Quadram Institute Bioscience
Norfolk and Norwich University Hospitals NHS Foundation Trust
Investigators
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Study Chair: Arjan Narbad, Prof Quadram Institute Bioscience
Principal Investigator: Melanie Pascale, PhD Quadram Institute Clinical Research Facility

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Responsible Party: Quadram Institute Bioscience
ClinicalTrials.gov Identifier: NCT03917693     History of Changes
Other Study ID Numbers: QIB03-2018
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No