The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Reading

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Raising the Pulse faba bean-enriched bread

    Other intervention

    100 g of white bread produced using 40% faba bean enriched flour and 60% wheat flour will be provided in the breakfast meal with stork margarine, chocolate spread, a glass of orange juice and a glass of water containing the iron-57 stable isotope. An ad-libitum lunch consisting of pasta and a tomato sauce will be provide 6 hours after the breakfast.

  • Conventional White Bread

    Other intervention

    100 g of white bread produced using 100% wheat flour will be provided in the breakfast meal with stork margarine, chocolate spread, a glass of orange juice and a glass of water containing the iron-57 stable isotope. An ad-libitum lunch consisting of pasta and a tomato sauce will be provide 6 hours after the breakfast.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Faba bean-enriched bread.Active comparator 1 intervention
Group B: Conventional white breadPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

The measurement of iron-57 in whole blood is a validated method for determining the absorption of iron from the bread given in the test meals (also known as bioavailability)

Time frame
Day 0 (baseline), day 30 and day 60

Secondary outcomes

1

Fasting concentrations of iron status markers

Serum ferritin (a measure of the level of iron stored by the body) and soluble transferrin receptor (a measure of functional iron status) will be measured by immunoassay.

Time frame
Day 0 (baseline), day 30 and day 60
2

Fasting concentration of C-reactive protein (a marker of inflammation)

Inflammation, which is characterised by the acute-phase response to infection, can directly affect the concentrations of most iron status markers. C-reactive protein will be measured in the fasting blood sample collected at each study visit to aid the interpretation of the data for the iron status markers.

Time frame
Day 0 (baseline), day 30 and day 60
3

Fasting levels of the full blood count parameters

The level of white blood cells, red blood cells, platelets, haematocrit and haemoglobin in the whole blood sample will be measured using a haematology analyser.

Time frame
Day 0 (baseline), day 30 and day 60
4

Fasting concentration of total cholesterol, high-density lipoprotein-cholesterol, triacylglycerol and non-esterified fatty acids.

Serum lipids will be measured directly using a clinical chemistry analyser.

Time frame
Day 0 (baseline), day 30 and day 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Reading

Lead sponsor

King's College London

Collaborator

University of Leeds

Collaborator