The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety (NCT06466746) | Clinical Trial Compass
RecruitingNot Applicable
The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety
United Kingdom16 participantsStarted 2024-09
Plain-language summary
High levels of animal proteins (meat) in the diet are linked with a greater risk of developing heart disease and other long-term health conditions. Recently there has been a shift to plant-based diets including plant proteins such as pulses, defined as beans, peas, chickpeas and lentils. Pulses are a nutritious and sustainable form of plant protein which are rich in fibre and iron. Despite this, the UK population does not consume the recommended daily amount of pulses (80g/day equivalent to a large handful). In contrast, bread is commonly consumed but very little is known about how bread enriched with pulses influences the amount of iron that is digested and absorbed by the body as well as risk factors for developing heart disease and type 2 diabetes.
The main purpose of this randomised controlled cross-over study is to determine how consuming bread enriched with pulses (in the form of faba bean flour at approximately 40% enrichment) compared with conventional white bread (100% wheat flour) influences the amount of iron absorbed in healthy males and females aged 18-50 years with low iron stores. Secondary aims are determining the effects on blood fats and sugar (glucose) and on feelings of fullness (also known as satiety) after eating the bread enriched in pulses and conventional white bread.
Participants will be required:
* To attend for seven study visits over a period of 60 days.
* Consume a breakfast meal containing either the faba bean-enriched bread or conventional bread over two study periods, each consisting of one 7 hour study visit and two consecutive visits of 2 hours in duration. After 28 days, participants will return for the second study period as above, with a final study visit conducted 28 days later.
* Give blood samples during 2 x 7 hour study visits
* Complete visual analogue scales to rate appetite after consuming the faba bean-enriched and conventional white bread.
* Record dietary intake prior to and during the study period.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-anaemic, males and pre-menopausal females (must have regular periods)
* Aged 18-50 years old
* BMI between 19 - 30 kg/m2
* Low iron stores (serum ferritin between 13-40 µg/L for females and 30-90 µg/L for males)
Exclusion Criteria:
* Food allergies or intolerances to faba beans (favism) or gluten
* Diagnosed with anaemia (haemoglobin \<115 g/L for females or \<130 g/L for males) or haemochromatosis
* C-reactive protein (\>3mg/L)
* Smokers
* A history of alcohol abuse (\> 14 units/ week)
* CVD or medical history of MI or stroke in the past 12 months
* Diabetes (fasting glucose \>7.0 mmol/L)
* Kidney, liver, pancreas or intestinal disease, gastrointestinal disorder or use of drugs likely to alter gastrointestinal function
* Pregnancy, planning a pregnancy in the next six months or breastfeeding
* Peri- and post-menopausal women or women with irregular periods
* Planning on a weight-reducing regimen (lost \>3kg in last 6 months)
* Parallel participation in another intervention study
* Hypertension (blood pressure \> 140/90 mmHg), cancer, taking medication for hyperlipidaemia (statins), or inflammation
* Taking vitamin or mineral supplements
* Donated blood in the last 3 months
* Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study (such as a pacemaker)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Given that I have iron deficiency or low iron stores, could participating in a study where I eat faba bean-enriched bread be appropriate for my current condition, or would I be better off starting standard iron treatment first?
2This trial is measuring how much iron my body actually absorbs using a special iron-57 stable isotope tracer over 30 days — is that kind of testing safe for me, and does it involve anything beyond dietary changes and blood draws?
3Since this trial is looking at both iron absorption and effects on blood fats after meals, could the results be relevant to my overall cardiometabolic health, and is that something worth factoring into my care plan?
4This study is still in the recruiting phase with no assigned phase label, which suggests it's exploratory — does that mean there's less established evidence about whether faba bean bread actually improves iron status, and what would that mean for managing my deficiency during the study period?
5What are the practical demands of this trial, like how often I'd need to come in, whether I'd need to stick to a specific diet, and whether those requirements are realistic given everything else I'm managing with my health right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the enrichment of whole blood haemoglobin with iron-57 stable isotope 30 days after consuming the faba bean-enriched bread and conventional bread.