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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
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|
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
- 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.
- 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
- 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
- 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
- Iron concentrations [ Time Frame: 4 months ]To determine whether the consumption of phytin causes a change in the available iron present in the faeces
- 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
- Gut inflammation [ Time Frame: 4 months ]To determine levels of calprotectin as a marker of gut inflammation
- Systemic inflammation [ Time Frame: 4 months ]To determine levels of C-Reactive Protein (CRP) as a marker of systemic inflammation
- Release of capsule [ Time Frame: 4 months ]To measure serum ferritin levels as a marker of the time of capsule release
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
|Contact: Bhavika Parmanand||+4401603255021||Bhavika.Parmanand@quadram.ac.uk|
|Contact: Lee Kellingray, Phdfirstname.lastname@example.org|
|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 email@example.com|
|Study Chair:||Arjan Narbad, Prof||Quadram Institute Bioscience|
|Principal Investigator:||Melanie Pascale, PhD||Quadram Institute Clinical Research Facility|