Effect of Phytin on Human Gut Microbiome (EPoM)

NCT03917693 | Completed

• 1 other identifier: QIB03-2018
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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, 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).

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (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.

  4 months

Secondary Outcomes (8)

• Relative abundance of Bifidobacteriaceae

  4 months

• Gut microbial composition

  4 months

• Short chain fatty acids

  4 months

• Iron concentrations

  4 months

• Phytin degradation

  4 months

Study Arms (2)

Phytin capsules

ACTIVE COMPARATOR

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

Microcrystalline cellulose (MCC) capsules

PLACEBO COMPARATOR

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

Interventions

Phytin, rice extract DIETARY_SUPPLEMENT

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

Phytin capsules

MCC, placebo OTHER

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

Microcrystalline cellulose (MCC) capsules

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Quadram Institute Bioscience

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

QI NNUHFT Clinical Research Facility

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

MeSH Terms

Interventions

Phytic Acid

Intervention Hierarchy (Ancestors)

Inositol Phosphates; Inositol; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Sugar Phosphates

Study Officials

• Arjan Narbad, Prof

  Quadram Institute Bioscience

  STUDY CHAIR

• Melanie Pascale, PhD

  Quadram Institute Clinical Research Facility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This process will be carried out by a QIB scientist who is not part of the study team. Wendy Hollands (QIB Food Innovation and Health \[FIH\] scientist) will be responsible for this process, and therefore ensures the trial remains blinded to the study participants, Chief Investigators and study scientists/advisors.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 17, 2019
• Study Start: May 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: February 12, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

GB (2)