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

Diet Modification Clinical Trial

Official title: A Human Intervention Trial Investigating the Effects of Phytin on the Human Gut Microbiome

Status Completed

Clinical Trial 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, the gut contains trillions of bacteria, many of which help to unlock extra nutrients from the food people 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, it is possible that the large intestine could populate more more harmful bacteria than beneficial bacteria.

In this study, investigators 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. The investigators are interested in whether consuming these capsules will decrease Enterobacteria (one of the 'bad bacteria' in the large intestine).

Clinical Trial 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 Participant Information Sheet (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. ;

Related Conditions & MeSH terms

• Diet Modification

• NCT number: NCT03917693
• Study type: Interventional
• Source: Quadram Institute Bioscience
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Completion date: February 12, 2020