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Diet ModificationEPoMNCT03917693

Effect of Phytin on Human Gut Microbiome (EPoM)

A study testing Phytin, rice extract in people with Diet Modification, run by Quadram Institute Bioscience at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Diet Modification
What is being tested?
Phytin, rice extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
2 sitesUnited Kingdom
Study dates
1 May 2019to 12 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Quadram Institute Bioscience

    Norwich, Norfolk, NR4 7UA

  • QI NNUHFT Clinical Research Facility

    Norwich, Norfolk, NR4 7UQ

Other trials in United Kingdom

About this study

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

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).

Read the 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 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.

Being tested
Phytin, rice extract, MCC, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phytin, rice extractDietary supplement

    Consumption of a rice extract, called phytin for a period of 2 weeks

  • MCC, placeboOther

    Consumption of MCC, a placebo, for a period of 2 week

Study groups in NCT03917693
Study groupRoleWhat they receive
Phytin capsulesActive comparator2.4 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.
Receives: Dietary Supplement: Phytin, rice extract
Microcrystalline cellulose (MCC) capsulesPlacebo comparator2.4 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.
Receives: Other: MCC, placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months

Secondary outcomes (8)

  1. 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

    Measured: 4 months

  2. 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

    Measured: 4 months

  3. 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

    Measured: 4 months

  4. Iron concentrations

    To determine whether the consumption of phytin causes a change in the available iron present in the faeces

    Measured: 4 months

  5. 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

    Measured: 4 months

  6. Gut inflammation

    To determine levels of calprotectin as a marker of gut inflammation

    Measured: 4 months

  7. Systemic inflammation

    To determine levels of C-Reactive Protein (CRP) as a marker of systemic inflammation

    Measured: 4 months

  8. Release of capsule

    To measure serum ferritin levels as a marker of the time of capsule release

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2019
  2. Study start1 May 2019
  3. Primary completion30 Aug 2019
  4. Study completion12 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03917693
Sponsor's protocol ID
QIB03-2018
Acronym
EPoM
Status last verified
Mar 2020
First submitted
12 Apr 2019
Last updated
17 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Phytin, rice extract in people with Diet Modification, run by Quadram Institute Bioscience at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative abundance of Enterobacteriaceae (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03917693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

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