Effect of Phytin on Human Gut Microbiome (EPoM)

Diet Modification Clinical Trial

— EPoM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917693
• Other study ID #: QIB03-2018
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: March 2020
• Source: Quadram Institute Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 12, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 the participant is 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. Participant may be able to take part 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 participant regularly takes pre-&/or pro biotics (3+ times a week, and for more than one month) and will continue throughout the study then participant 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 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

• 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 participant's stools or have two or more episodes of constipation or diarrhoea (type 1, 2, or 7 stools) during the study

• are unwilling to provide their General Practioner's (GP's) 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)

Related Conditions & MeSH terms

• Diet Modification

Intervention

Dietary Supplement:
• Phytin, rice extract
Consumption of a rice extract, called phytin for a period of 2 weeks

Other:
• MCC, placebo
Consumption of MCC, a placebo, for a period of 2 week

Locations

Country	Name	City	State
United Kingdom	QI NNUHFT Clinical Research Facility	Norwich	Norfolk
United Kingdom	Quadram Institute Bioscience	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
Quadram Institute Bioscience	Norfolk and Norwich University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative abundance of Enterobacteriaceae	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.	4 months
Secondary	Relative abundance of Bifidobacteriaceae	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	4 months
Secondary	Gut microbial composition	To ascertain whether consuming phytin modulates the gut microbial community as a whole, as compared to the consumption of a placebo capsule	4 months
Secondary	Short chain fatty acids	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 months
Secondary	Iron concentrations	To determine whether the consumption of phytin causes a change in the available iron present in the faeces	4 months
Secondary	Phytin degradation	To ascertain the extent of phytin degradation that takes place in the colon based on the known concentration of phytin administered via the capsule	4 months
Secondary	Gut inflammation	To determine levels of calprotectin as a marker of gut inflammation	4 months
Secondary	Systemic inflammation	To determine levels of C-Reactive Protein (CRP) as a marker of systemic inflammation	4 months
Secondary	Release of capsule	To measure serum ferritin levels as a marker of the time of capsule release	4 months